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Field Mapping for the MedWatch Report


Table 37 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.

Table 37. Mapping of Fields from the Siebel AECM UI to the MedWatch 3500A Form
Location on MedWatch Form 3500A
Field Name
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

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