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Field Mapping for the MDV Report


Table 38 shows how the fields in the Regulatory Reports screen map to the fields in the MDV report.

Table 38. Mapping of Fields from Siebel AECM UI to the MDV Report
Regulatory Reports Screen
UI Field Name
View (Applet) on the Regulatory Reports and the Product Issues screen
Text on MDV Report

Report Header

Report #

MDV Report #

More Info

MDV

MDV Report #

Report Header

Affiliate Ref #

MDV

Affiliate Ref #

Report Header

Type

More Info

Report Type

MDV Determination

Determination

 

MDV

 

MDV Determination

Destination

Authorities

 

MDV

 

Competent Authority Name

Destination

Address

Address 2

City

State

Postal Code

Country

MDV

Address

General

Report Date

More Info, Regulatory Reports screen only

Report Date

General

Received

More Info

Manufacturer Awareness Date

General

Affiliate Acct

MDV

Reporting Firm Name

General

Auth Rep

First Name

MDV

Authorized Representative

General

Address

City

State

Postal Code

Country

MDV

Address

General

Phone #

MDV

Telephone

General

Fax #

MDV

Facsimile

Event Information

Patient Identifier

Patient

Patient Identifier

Event Information

Gender

Patient

Gender

Event Information

Age

Patient

Age

Event Information

Weight

Patient

Weight

Event Information

Date of Birth

Patient

Date of Birth

Event Information

Account

More Info

Health Care Facility Name

Event Information

Site

More Info

Site

Event Information

Contacts, First Name

More Info

Contact Name

Event Information

Address

More Info

Address

Event Information

Phone #

More Info

Contact Phone Number

Event Information

Event Date

More Info (Event Detail)

Event Date

Event Information

Description

More Info (Event Detail)

Event Description

Event Information

# Occurrences

More Info (Event Detail)

Number of Occurrences

Event Information

Labeled Single Use

More Info (Products)

Investigation

Device Labeled for Single Use

Event Information

Patient Codes

MDV

Importer

Patient Outcomes

Event Information

Device Codes

MDV

Importer

Device Outcomes

Event Information

Usage of Device

MDV

Investigation

Usage of Device

Event Information

Authorities

MDV

Competent Authorities Already Notified

Device Information

Mfg Name

MDV

Manufacturer Name

Device Information

Contact

First Name

MDV

Manufacturer Contact Name

Device Information

Address

City

State

Postal Code

Country

MDV

Address

Device Information

Phone #

MDV

Telephone

Device Information

Fax #

MDV

Facsimile

Device Information

Product

More Info (Products)

Device Name

Device Information

Device Type

More Info (Products)

Type of Device

Device Information

Lot #

More Info (Products)

Device Lot #

Device Information

Part #

More Info (Products)

Device Part #

Device Information

Asset #

More Info (Products)

Device Asset #

Device Information

Serial #

More Info (Products)

Device Serial #

Device Information

Model #

More Info (Products)

Model #

Device Information

Catalog #

More Info (Products)

Catalog #

Device Information

Approval Org

MDV

Device Approval Body

Device Information

Approval #

MDV

Approval #

Device Information

Qty Involved

More Info (Products)

Quantity of Devices Involved

Device Information

Device Available

More Info (Products)

Device Disposition

Device Information

External Products

More Info (Event Detail)

Associated Products

Results of Investigation

Evaluation

MDV

Investigation

Device Evaluation Result

Results of Investigation

Remedials

MDV

Remedial Action

Results of Investigation

MFG Narrative

MDV

Investigation

Manufacturer's Narrative

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