Table 37. Mapping of Fields from the Siebel AECM UI to the MedWatch 3500A Form
Location on MedWatch Form 3500A |
|
View (Applet) on the Regulatory Reports and the Product Issues screen |
A. Patient Information |
A1 |
Patient Identifier |
Patient |
A2 |
Age |
Patient |
A2 |
Date of Birth |
Patient |
A3 |
Gender |
Patient |
A4 |
U/M |
Patient |
A4 |
Weight |
Patient |
B. Adverse Event or Product Problem |
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) |
C. Suspect Medication(s) |
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) |
D. Suspect Medical Device |
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) |
E. Initial Reporter |
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 |
F. For Use by User Facility/Importer (Devices Only) |
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 |
G. All Manufacturers |
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 |
H. Device Manufacturers Only |
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 |