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