Field Mapping for the MedWatch Report
The following table shows how the fields in the Regulatory Reports screen map to the fields in the MedWatch 3500A report. If the content for text fields extends to continuation pages, it starts from the third page. Note the following about the different areas on the Location MedWatch Form 3500A:
A: Patient Information
B: Adverse Event or Product Problem
C: Suspect Medication(s)
D: Suspect Medical Device
E: Initial Reporter
F: For Use by User Facility/Importer (Devices Only)
G: All Manufacturers
H: Device Manufacturers Only
Location on MedWatch Form 3500A Field Name View (Applet) on the Regulatory Reports and the Product Issues screen A1
Patient Identifier
Patient
A2
Age
Patient
A2
Date of Birth
Patient
A3
Gender
Patient
A4
U/M
Patient
A4
Weight
Patient
B1
Event Type
More Info (Event Detail)
B2
Congenital Anomaly
More Info (Event Detail)
B2
Date of Death
More Info (Event Detail)
B2
Death
More Info (Event Detail)
B2
Disability
More Info (Event Detail)
B2
Hospitalization
More Info (Event Detail)
B2
Life Threatening
More Info (Event Detail)
B2
Other
More Info (Event Detail)
B2
Required Intervention
More Info (Event Detail)
B3
Event Date
More Info (Event Detail)
B4
Report Date
More Info, Regulatory Reports screen only
B5
Description
More Info (Event Detail)
B6
Tests/Data
More Info (Event Detail)
B7
Relevant History
More Info (Event Detail)
C1
Product
More Info (Products)
C2
Dose Per Unit
More Info (Products)
C2
Frequency
More Info (Products)
C2
Route Used
More Info (Products)
C3
Therapy From Date
More Info (Products)
C3
Therapy To Date
More Info (Products)
C4
Indication
More Info (Products)
C5
Event Abated
More Info (Products)
C6
Lot #
More Info (Products)
C7
Expiration Date
More Info (Products)
C8
Reintroduce Reoccur
More Info (Products)
C9
NDC#
More Info (Products)
C10
External Products
More Info (Event Detail)
D1
Product
More Info (Products)
D2
Common Device Name
More Info (Products)
D3
City
More Info (Products)
D3
Mfg Name
More Info (Products)
D3
Postal Code
More Info (Products)
D3
State
More Info (Products)
D3
Street Address
More Info (Products)
D4
Asset #
More Info (Products)
D4
Catalog #
More Info (Products)
D4
Expiration Date
More Info (Products)
D4
Lot #
More Info (Products)
D4
Model #
More Info (Products)
D4
Part #
More Info (Products)
D4
Serial #
More Info (Products)
D5
Device Operator
More Info (Products)
D6
Implant Date
More Info (Products)
D7
Explant Date
More Info (Products)
D8
Reprocessed
More Info (Products)
D9
Reprocessor
More Info (Products)
D10
Device Available
More Info (Products)
D10
Return Date
More Info (Products)
D11
External Products
More Info (Event Detail)
E1
Account
More Info
E1
Address
More Info
E1
City
More Info
E1
Contacts (Contact Last Name in list)
More Info
E1
CSN #
More Info
E1
First Name (Contact First Name in list)
More Info
E1
Phone #
More Info
E1
Postal Code
More Info
E1
Site
More Info
E1
State
More Info
E2
Provider
More Info
E3
Occupation
More Info
E4
Reported FDA
More Info
F1
Facility Type
Importer
F2
Report #
Importer
F3
Address
Importer
F3
City
Importer
F3
Country
Importer
F3
Importer
Importer
F3
Postal Code
Importer
F3
State
Importer
F4
Contact Name
Importer
F4
First Name
Importer
F5
Phone #
Importer
F6
PI Received
Importer
F7
Follow-up #
Importer
F7
Report Type
Importer
F8
Report Date
More Info
F9
Age UoM
Importer
F9
Device Age
Importer
F10
Device Codes
Importer
F10
Patient Codes
Importer
F11
FDA Report Date
Importer
F11
Reported FDA
Importer
F12
Event Location
Importer
F13
Mfg Report Date
Importer
F13
Reported Mfg
Importer
G1
Address
Manufacturer
G1
City
Manufacturer
G1
Contact Name
Manufacturer
G1
Contact Office
Manufacturer
G1
Country
Manufacturer
G1
First Name
Manufacturer
G1
Postal Code
Manufacturer
G1
State
Manufacturer
G2
Phone #
Manufacturer
G3
Consumer
Manufacturer
G3
Foreign
Manufacturer
G3
Distributor
Manufacturer
G3
Literature
Manufacturer
G3
Other
Manufacturer
G3
Professional
Manufacturer
G3
Representative
Manufacturer
G3
Study
Manufacturer
G3
User Facility
Manufacturer
G4
PI Received
Manufacturer
G5
(A)NDA #
Manufacturer
G5
IND #
Manufacturer
G5
OTC Product
Manufacturer
G5
Pre-1938
Manufacturer
G6
Protocol #
More Info (Product Issues) and Manufacturer
G7
10-day
Manufacturer
G7
15-day
Manufacturer
G7
5-day
Manufacturer
G7
Follow-up
Manufacturer
G7
Follow-Up #
Manufacturer
G7
Initial
Manufacturer
G7
Periodic
Manufacturer
G8
AE Terms
Manufacturer
G9
Mfg Report #
Manufacturer
H1
Death
Investigation
H1
Malfunction
Investigation
H1
Other
Investigation
H1
Serious Injury
Investigation
H2
Additional Information
Investigation
H2
Correction
Investigation
H2
Device Evaluation
Investigation
H2
Response to FDA Request
Investigation
H3
Evaluated by Mfg
Investigation
H3
Evaluation
Investigation
MDV
H3
Non-Evaluation Codes
Investigation
H4
Mfg Date
Investigation
More Info (Products)
H5
Labeled Single Use
More Info (Products)
Investigation
H6
Conclusion Codes
Investigation
H6
Method Codes
Investigation
H6
Result Codes
Investigation
H7
Inspection
Investigation
H7
Modification
Investigation
H7
Notification
Investigation
H7
Other
Investigation
H7
Patient Monitoring
Investigation
H7
Recall
Investigation
H7
Relabeling
Investigation
H7
Repair
Investigation
H7
Replace
Investigation
H8
Usage of Device
Investigation
H9
Correction #
Investigation
H10
Mfg Narrative
Investigation
MDV
H11
Corrected Data
Investigation