FDA 3500A Generation Data Mapping

Learn how Vault generates the FDA MedWatch 3500A form from a Case.

The following list describes how Vault handles certain data while generating FDA MedWatch 3500A forms:

  • For events, diagnoses, indications, test names, and medical conditions, Vault Safety always populates the MedDRA Lowest Level Term (LLT) when there is a coded value available. If there is no MedDRA term available, the reported term is used.
  • Dates are populated using the format dd-mmm-yyyy. Blank dates are populated as dashes (---).
  • Certain fields may be masked, depending on the blinding settings on the Case or masking settings on the Distribution. Generate Masked Distributions describes the fields that may be masked.
  • Open-label Products within blinded Studies may be unmasked, depending on your Admin’s configuration of Show Unmasked Open-Label Products on Blinded Forms
  • Case Products with a Drug Role of Suspect, Interacting, or Drug Not Administered are mapped to form sections as shown in the following table:
Case Product Type Product Type Sections
Company Product
  • Device
  • OTC Device
 D. Suspect Medical Device
H. Device Manufacturers Only
Company Product
  • Drug
  • Biologic
  • Vaccine
  • Combination Product
  • Cosmetic
  • OTC Drug
  • Nutritional
 C. Suspect Products
External Product Device D. Suspect Medical Device
H. Device Manufacturers Only
External Product Any type other than Device C. Suspect Products
Study Product Device D. Suspect Medical Device
H. Device Manufacturers Only
Study Product Any type other than Device C. Suspect Products

Optional Configuration

To evaluate Case Products with the Drug Role of Drug Not Administered as suspect, your Admin must have enabled Extend Definition of Suspect to Drug Not Administered. Otherwise, Vault evaluates only Case Products with a Drug Role of Suspect or Interacting as suspect.

FDA 3500A Header Section

FDA MedWatch 3500A Field Populated Value
Mfr. Report #

For device Cases, Vault exports the value in the Manufacturer Site Number field of the Organization related to the Device-type Case Product, the current calendar year, and the number of FDA MedWatch 3500A format Transmissions in the Completed state for the same Case Product when the Drug Role is Suspect. Vault exports the values using the following format: Manufacturer Site Number-Year-Count.

For non-device Cases and device Cases on which the Manufacturer Site Number field is blank. Vault populates the value in the UID field of the Case.
UF/Importer Report # Vault does not populate this field.
Exemption/Variance # Vault does not populate this field.

A. Patient Information

A. Patient Information Section

FDA MedWatch 3500A Field Populated Value
1. Patient Identifier The value in the Patient Initials / ID field on the Case. If this field is blank, Vault populates the value entered in the Investigation MRN field.
2. Age The value from one (1) of the following Case fields, ordered by priority:
  1. Age (value and unit)
  2. Age (normalized)
2. Date of Birth The date in the Date of Birth field on the Case.
3a. Sex The value in the Sex field on the Case as follows:
  • If the Sex field is set to Male, Vault selects the Male checkbox.
  • If the Sex field is set to Female, Vault selects the Female checkbox.
  • If the Sex field is set to Not Asked or Unknown, Vault selects the Undifferentiated checkbox.
  • If the Sex field is set to Asked But Unknown, Vault selects the Decline to answer checkbox.
3b. Gender The value in the Gender field on the Case as follows:
  • If the Gender field is set to Cisgender Man, Vault selects the Cisgender man/boy checkbox.
  • If the Gender field is set to Cisgender Woman, Vault selects the Cisgender woman/girl checkbox.
  • If the Gender field is set to Transgender Man/FtM, Vault selects the Transgender man/trans man/female-to-male (FTM) checkbox.
  • If the Gender field is set to Transgender Woman/MtF, Vault selects the Transgender woman/trans woman/male-to-female (MTF) checkbox.
  • If the Gender field is set to any other value, Vault selects the Other gender category; please specify: checkbox and populates any custom text entry in the field.
  • If the Gender field is blank, Vault selects the Decline to answer checkbox.
4. Weight The value from one (1) of the following Case fields, ordered by priority:
  1. Weight (value and unit)
  2. Weight (normalized)
5. Ethnicity The value from the Ethnicity field on the Case.
6. Race The value from the Race field on the Case.

B. Adverse Event or Product Problem

B. Adverse Event or Product Problem Section

FDA MedWatch 3500A Field Populated Value
1. Type of Report Based on the report type, Vault selects:
  • For non-device Cases, the Adverse Event checkbox.
  • For device or Combination Product Cases, one (1) or both checkboxes. Vault selects the Product Problem checkbox if the Device Report Type includes Malfunction or Product Problem.
2. Outcome Attributed to Adverse Event Vault selects the appropriate checkbox based on the Seriousness field in the Details section of the Case. If the adverse event resulted in death, Vault populates the date in the Date of Death field on the Case.
3. Date of Event The earliest Onset Date for any Case Adverse Event associated with the Case version.
4. Date of this Report The date when the report was generated, according to the Vault's Timezone.
5. Describe Event or Problem Any text in the Narrative on the Case. After the narrative text, Vault populates any text in the Company Comments field. If the narrative text overflows onto additional pages, Company Comments also appear on the overflow pages.
6. Relevant Test/Laboratory Data

Vault populates a row for each Case Test Result record on the Case, sorted alphabetically and from oldest to latest. Lab Test Results with no Test Date appear at the end of the list.

The information exported includes:

  • Test Name (LLT) and Test Name (Reported)
  • Result (Unit) or Result (Unit) Text
  • Result (Code) or Result (qualifier) and Result and Result (Unit)
  • Test Name (LLT) and Test Name (Reported), Result
  • Test Date

Text that exceeds the available space appears on overflow pages.
6. Additional comments

For each Case Test Result record in the B6. Relevant Test/Laboratory Data section, Vault populates the following information when available:

  • Normal Low Value - Normal High Value and the unit in the Test Result field or the Result (Unit) Text field
  • Comments
  • Result (Text)

In addition, for adverse events that resulted in death, the following information is populated from each Case Cause of Death record:

  • Reported Causes of Death: Cause (MedDRA) or Cause (Reported)
  • Autopsy-Determined Cause of Death: Cause (MedDRA) or Cause (Reported)

Text that exceeds the available space appears on overflow pages.
7. Other Relevant History, Including Preexisting Medical Conditions

The following information is repeated for each Case Medical History record, populated from the following fields:

  • Condition / Procedure (MedDRA) or Condition / Procedure (Reported)
  • Start Date or ---, End Date or ---, Continuing
  • Comments

After listing each medical history line item, Vault populates any text in the Medical History Text field on the Case.

C. Suspect Products

C. Suspect Product(s) Section

FDA MedWatch 3500A Field Populated Value
1. Name, Strength, Manufacturer/Compounder

For Case Products assigned a Drug Role of Suspect, Interacting, or Drug Not Administered, Vault populates:

  • Product Name: Depending on your Admin's configuration, Vault first attempts to map the Product (Reported) to the Product (Coded) value from the Case Product. If the configured default value is blank, Vault maps the other value, if available.
  • Strength: The Strength on the associated Product Registration record.
  • Unit: The Unit on the associated Product Registration record.
  • NDC # or Unique ID: The National Drug Code on the associated Product Registration record.
  • Manufacturer/Compounder Name: The value in the Manufacturer field on the Product record. If blank, Vault maps the value in the Organization field on the associated Product Family.
  • Lot #: The value in the Batch/Lot Number field on the associated Product Dosage record on the Case.
2. List Medical Product and Treatment Given at the Same Time of the Event and Date

For each associated Case Product record, Vault populates:

  • Product or Product (Reported)
  • First Admin Date or --- or unk, Last Admin Date or --- or unk, Duration, Action Taken
  • Dose or Dose Text and Frequency
  • Indication (MedDRA) or Indication (Reported)

If the Therapy dates are unknown, Vault populates this field with the value from the Duration field. Vault updates the Duration field value to Ongoing if any of the following values are in the Action Taken field:

  • Dose reduced
  • Dose increased
  • Dose not changed
3. Dose, Frequency, Route Used

For Case Products assigned a Drug Role of Suspect, Interacting, or Drug Not Administered, Vault populates:

  • Dose or Amount: The text value in the Dose field.
  • Unit: The unit value in the Dose field or UNKNOWN - UNK.
  • Frequency: The value and unit in the Frequency field as follows:
    • If set to Every 1 days or 1 times per days, Vault exports Daily
    • If set to 2 times per days, Vault exports BID
    • If set to 3 times per days, Vault exports TID
    • If set to 4 times per days, Vault exports QID
    • If set to Other > as necessary, Vault exports PRN
    • For all other settings, Vault exports Other and maps the Frequency text to the Other Frequency box on the form.
  • Route: The value in the Patient RoA field or Vault exports Other and maps the Patient RoA text to the Other Route box on the form. If the Patient RoA field is blank or has a Reasons Omitted value, Vault exports Unknown.
4. Treatment Dates/Therapy Dates

Vault populates information from the following Product Dosage fields from the Case:

First Admin Date or --- or unk, Last Admin Date or --- or unk, Duration

If the Therapy dates are unknown, Vault populates this field ith the value from the Duration field. Vault updates the Duration field value to Ongoing if any of the following values are in the Action Taken field:

  • Dose reduced
  • Dose increased
  • Dose not changed
5. Diagnosis for use The value in either the Name (MedDRA) or Indication (Reported) field on the associated Product Indication record on the Case.
6. Product Type Vault maps values from the applicable FDA Product Registration to select checkboxes.
7. Expiration Date The date in the Expiration Date field on the associated Case Product.
8. Event Abated after use Stopped or Dose Reduced? Vault uses the following fields to calculate whether a dechallenge test occurred and populates the appropriate checkbox:
  • Action Taken on the primary Case Product
  • Outcome on the primary Case Adverse Event

The following table outlines how Vault populates the form based on the field values:

Action Taken (G.k.8) E2B Code* Outcome (E.i.7) FDA 3500A C.9 Box
Drug Withdrawn
Dose Reduced		 1
2		 Recovered/Resolved
Recovering/Resolving
Recovered/Resolved with Sequalea		 Yes
Drug Withdrawn
Dose Reduced		 1
2		 Not Recovered
Not Resolved
Ongoing
Fatal		 No
Drug Withdrawn
Dose Reduced		 1
2		 Unknown (blank) (blank)
Dose Increased
Dose Not Changed
Not Applicable		 3
4
9		 Any Doesn't apply
Unknown 0 Any (blank)
Any other condition (blank)
*Includes custom Action Taken Controlled Vocabulary records
9. Event Reappeared After Reintroduction? Vault uses the Reaction Recurrence field on the primary Case Assessment to determine whether a rechallenge test occurred and populate the appropriate checkbox.
  • If the Reaction Recurrence field is set to yes – yes (rechallenge was done, reaction recurred), then the Yes checkbox is selected.
  • If the Reaction Recurrence field is set to yes - no (rechallenge was done, reaction did not recur), then the No checkbox is selected.
  • If the Reaction Recurrence field is set to any of the following options, then the Doesn't apply checkbox is selected:
    • yes - unk (rechallenge was done, outcome unknown)
    • no - n/a (no rechallenge was done, recurrance is not applicable)
    • The field is left blank

D. Suspect Medical Device

D. Suspect Medical Device Section

FDA MedWatch 3500A Field Populated Value
1. Brand Name The value in the Product (Reported) field on the Device-type Case Product.
2a. Common Device Name The value in the Generic Name field on the Product.
2b. Procode The value in the Product Code field on the associated Product Registration.
3. Manufacturer Name, City and State If an organization is selected in the Manufacturer field on the associated Product Family record, Vault populates the associated name, city, and state. Otherwise, Vault populates the value in the Organization field of the associated Product Family.
4. Model # The value in the Model Number field on the Device-type Case Product.
4. Lot # The value in the Lot Number field on the Device-type Case Product.
4. Catalog # The value in the Catalog Number field on the Device-type Case Product.
4. Expiration Date The value in the Expiration Date field on the Device-type Case Product.
4. Serial # The value in the Serial Number field on the Device-type Case Product.
4. Unique Device Identifier (UDI)# The value in the Unique Identifier field on the Device-type Case Product.
5. Operator of Device The value in the Operator of Device field on the Device-type Case Product. If the value is Other, Vault selects the Other checkbox and populates the value in the Operator of Device (Other) field.
6a. If Implanted, Give Date The date in the Date Implanted field on the Device-type Case Product.
6b. If Explanted, Give Date The date in the Date Explanted field on the Device-type Case Product.
7a. Is this a single-use device that was reprocessed and reused on a patient? Vault selects the appropriate checkbox based on the Reprocessed/Reused field on the Device-type Case Product.
7b. If yes, enter the name and address of the reprocessor The value in the Reprocessor field on the Device-type Case Product.
8. Was this device ever serviced by a third-party servicer? Vault selects the appropriate checkbox based on the value in the Third-party servicer for device? field on the Device-type Case Product.
9. Is this Device Available for Evaluation? Vault selects the appropriate checkbox based on the Device Available field on the Device-type Case Product. If there is a date in the Returned Date field, Vault populates the date and selects the Returned to Manufacturer checkbox.
10. Concomitant Medical Products and Therapy Dates

For each associated Case Product record, Vault populates values from the following fields:

  • Product or Product (Reported)
  • First Admin Date, Last Admin Date

E. Initial Reporter

E. Initial Reporter Section

FDA MedWatch 3500A Field Populated Value
1. Name and Address Vault populates the form fields using the name and address on the primary Reporter-type Case Contact record.
2. Health Professional? Vault selects the appropriate checkbox based on the value in the Qualification field on the primary Reporter-type Case Contact record.
3. Occupation The value in the Qualification field on the primary Reporter-type Case Contact record. Vault populates Non-Health Professional if the value is any of the following:
  • Consumer or other non health professional
  • Lawyer
  • Patient
  • Parent
4. Initial reporter also sent report to FDA Vault selects the appropriate checkbox based on the value in the Sent to FDA? field on the primary Reporter-type Case Contact record.

F. For Use by User Facility/Importer (Devices Only)

F. For Use by User Facility/Importer (Devices Only)

G. All Manufacturers

G. All Manufacturers Section

FDA MedWatch 3500A Field Populated Value
1. Contact Office (and Manufacturing Site for Devices) or Compounding Outsourcing Facility Vault populates the contact information for the user selected in the Sender User field on the associated Transmission (Submission or Distribution) record. When generating a form preview from the Case, the contact information is populated with the contact details for the Organization on the Case.
2. Report Source Vault selects the appropriate checkboxes as follows:
Checkbox Logic
Foreign Checked based on the Country field on the primary Reporter-type Case Contact.
Study Checked when the Report Type of the Case corresponds to a Report Type Controlled Vocabulary where the E2B Code is 2, for example, Study or Literature (Study).
Literature Checked when the Report Type of the Case corresponds to a Report Type Controlled Vocabulary where Literature is set to Yes, for example, Literature (Spontaneous) or Literature (Study).
Consumer Checked when the Qualification of the Reporter-type Case Contact corresponds to a Qualification Controlled Vocabulary where Qualified HCP is set to No, for example, Consumer or other non health professional.
Health Professional Checked when the Qualification of the Reporter-type Case Contact corresponds to a Qualification Controlled Vocabulary where Qualified HCP is set to Yes, for example, Physician.
User Facility Checked when FDA 3500A Report Source is set to User Facility on the primary Reporter-type Case Contact.
Company Representative Checked when FDA 3500A Report Source is set to Company Representative on the primary Reporter-type Case Contact.
Distributor Checked when FDA 3500A Report Source is set to Distributor on the primary Reporter-type Case Contact.
Other Checked when FDA 3500A Report Source is set to Other on the primary Reporter-type Case Contact. Vault also populates the value from the Case Identifier field from the associated Transmission (Submission or Distribution).
3. Date Received by Manufacturer

Vault uses the following logic to populate this field:

Initial Case: Vault maps the date from one (1) of the following Case fields, ordered by priority:

  1. New Info Date
  2. Initial Receipt Date

A Case is considered initial when it meets any of the following conditions:

  • For a report generated from a Transmission, the Transmission Reason field value must map to E2B Code I (Initial)
  • For a report preview generated from a Case, the Case Version must be less than or equal to 1.0

Follow-Up: Vault maps the date from the New Info Date field on the Case, if populated. A Case is considered follow-up when it meets any of the following conditions:

  • For a report generated from a Transmission, the Transmission Reason field value must not map to E2B Code I.
  • For a report preview generated from a Case, the Case Version must be greater than 1.0
4. NDA # If the Registration Type field on the associated Product Registration is set to NDA, Vault maps this value from the Registration Number field.
4. ANDA # If the Registration Type field on the associated Product Registration is set to ANDA, Vault maps this value from the Registration Number field.
4. IND #

For study Cases with a Study Type of Clinical Trial or blank, if there is a US Study Registration with a Registration Type of IND, Vault populates the IND number from the Study Registration Number field from that Study Registration.

In all other scenarios, if the Registration Type field on the associated Case Product Registration is set to IND, Vault takes this value from the Registration Number field.
4. BLA # If the Registration Type field on the associated Product Registration is set to BLA, Vault maps this value from the Registration Number field.
4. PMA/510(k) # If the Registration Type field on the associated Product Registration is set to either PMA or 510k, Vault maps this value from the Registration Number field.
4. Combination Product Vault selects this checkbox when any Case Product is part of a Combination Product.
4. Pre-ANDA Vault does not support this field
4. Pre-1938 If the International Birthdate on the associated Product record is set to a date earlier than 1938, Vault selects this checkbox.
4. OTC Across all Case Products in sections C and D, if any part of a Product has an FDA registration with the Registered As field set to a Transmission Product Type of OTC Drug or OTC Device, Vault selects the Yes checkbox.
4. Compounded Product Vault does not support this field
5. If IND/PreANDA, Give Protocol # The value in the Sponsor Study Number field on the Case.
6. Type of Report Vault selects the appropriate checkbox based on the value in the FDA Report Type field, which is set based on the Due in Days reporting rule parameter. Otherwise, Vault populates this checkbox based on the following logic:
  • 5-day: When the Device Report Type field on the Case contains Public Health Risk.
  • 7-day: When the Case is tagged as a SUSAR and the Seriousness field on the primary Case Adverse Event contains Results in Death or Life-Threatening.
  • 15-day: Vault selects this checkbox using the following logic:
    • For an initial study Case, the Case is tagged as a SUSAR and does not qualify for the 7-day option (for example, the Seriousness field on the primary Case Adverse Event does not contain Results in Death or Life-Threatening).
    • For a postmarket spontaneous Case, whether initial or follow-up, the Seriousness field on the primary Case Adverse Event is populated and the Case Expectedness is set to No.
  • 30-day: For device malfunction-only reports.
  • Periodic: When any of the following conditions are met:
    • The Seriousness field on the primary Case Adverse Event is not populated.
    • The Seriousness field on the primary Case Adverse Event is populated and the Case Expectedness field is set to Yes .
    • The Case is a follow-up study Case tagged as a SUSAR.
  • Initial and Follow-up #: Vault selects these checkboxes using the following logic:
    • If a Transmission record exists for the Case and a value is populated in the Transmission Reason field:
      1. If the Transmission Reason is Initial, Vault selects Initial.
      2. If the Transmission Reason is populated with any other value, Vault selects Follow-Up #.
    • If there is no Transmission record associated with the Case:
      1. If the Case New Info Date is on or before the Receipt Date, Vault selects Initial.
      2. If the Case New Info Date is later than the Receipt Date, Vault selects Follow-Up #.
Vault populates the Follow-up # value from the Follow-up Number field on the Submission record.
7. Adverse Event Term(s) The value in the Event (MedDRA) field or the Event (Reported) - English field on the primary Case Adverse Event record.
8. Manufacturer Report Number The value in the UID field on the Case.

H. Device Manufacturers Only

H. Device Manufacturers Only

FDA MedWatch 3500A Field Populated Value
1. Type of Reportable Event

Vault selects the Death checkbox if the Seriousness of any Case Adverse Event contains Results in death.

Vault selects the Serious Injury checkbox based on the value in the Device Report Type field on the Case.

Vault selects the Malfunction checkbox based on the value in the Malfunction field on the primary Device-type Case Product. If that field is blank, Vault selects a checkbox based on the Device Report Type field on the Case.

Vault does not support the Summary Report checkbox or the No. of events summarized field.
2. If Follow-up, What Type? Vault selects the appropriate checkboxes based on the Device Follow-Up Type field on the Case.
3. Device Evaluated by Manufacturer?

Vault selects the appropriate checkbox based on the Device Evaluated field on the associated Case Product as follows:

  • If set to Yes, Vault selects the Yes checkbox.
  • If set to No or Not Returned to Manufacturer, Vault selects the No checkbox.
4. Device Manufacture Date The value from the Manufacture Date field on the associated Case Product.
5. Labeled for Single Use? For Device-type Case Products, the value from the Single Use field.
6. Adverse Event Problem Based on the Device Type Code and Device Code on the Device-type Case Product, Vault populates the level 1, 2, or 3 FDA or IMDRF codes. To use IMDRF codes, your Admin must enable the IMDRF Dictionary for Maintenance, Case Processing, and Submissions. Vault populates this section as follows:

  • Health Effect - Clinical Code: If the Device Type Code is Health Effects - Clinical signs and Symptoms or Conditions, Vault exports up to three (3) FDA or IMDRF codes. If no Health Effect - Clinical Code codes are found, Vault populates the field with Unknown. If there are more than three (3) Health Effect - Clinical Code codes, all appear on the overflow pages instead of in this section.

  • Health Effect - Impact Code: If the Device Type Code is Health Effects - Health Impact, Vault exports up to three (3) FDA or IMDRF codes. If no Health Effect - Health Impact codes are found, Vault populates the field with Unknown. If there are more than three (3) Health Effect - Health Impact codes, all appear on the overflow pages instead of in this section.

  • Medical Device Problem Code: If the Device Type Code is Medical Device Problem, Vault exports up to three (3) FDA or IMDRF codes. If no Medical Device Problem codes are found, Vault populates the field with Unknown. If there are more than three (3) Medical Device Problem codes, all appear on the overflow pages instead of in this section.

  • Component Code: If the Device Type Code is Medical Device Component, Vault exports up to three (3) FDA or IMDRF codes. If no Medical Device Component codes are found, Vault populates the field with Unknown. If there are more than three (3) Medical Device Component codes, all appear on the overflow pages instead of in this section.

  • Type of Investigation: If the Device Type Code is Type of Investigation, Vault exports up to four (4) FDA or IMDRF codes. If no Type of Investigation codes are found, Vault populates the field with Unknown. If there are more than four (4) Type of Investigation codes, all appear on the overflow pages instead of in this section.

  • Investigation Findings: If the Device Type Code is Investigation Finding, Vault exports up to four (4) FDA or IMDRF codes. If no Investigation Finding codes are found, Vault populates the field with Unknown. If there are more than four (4) Investigation Finding codes, all appear on the overflow pages instead of in this section.

  • Investigation Conclusions: If the Device Type Code is Investigation Conclusion, Vault exports up to four (4) FDA or IMDRF codes. If no Investigation Conclusion codes are found, Vault populates the field with Unknown. If there are more than four (4) Investigation Conclusion codes, all appear on the overflow pages instead of in this section.
7. If Remedial Action Initiated, Check Type Vault selects the appropriate boxes using the following priority order:
  • The Remedial Action field on the primary Device-type Case Product. When populated with Other, Vault exports the text in the Remedial Action Other field of the Case Product.
  • The Remedial Action field on the Case. When populated with Other, Vault exports the text in the Remedial Action-Other field of the Case.
8. Usage of Device Vault selects the appropriate box based on the value in the Device Usage Type field on the associated Device-type Case Product.
9. If action reported to FDA under 21 USC 360i(g), list correction/removal reporting number The value from the Correction/Removal Reporting Number field on the associated Device-type Case Product.
10. Related Report Number Vault does not support this field.
11. Additional Manufacturer Narrative The text in the Additional Manufacturer Narrative field on the associated Device-type Case Product. Text that exceeds the field character limit appears in the overflow pages under the heading H.10 Additional Manufacturer Narrative.

Overflow Pages

When generating the FDA MedWatch 3500A form, Vault exports any text that exceeds field character limits to overflow pages. In the applicable field, Vault truncates the text to 15 characters and appends (Continued) to indicate the information is on the overflow pages. Any text on the overflow pages is identified with the relevant section and field names.