SECTION DISPLAY_TEXT Field Type

General Sender Email Text

Reporter Email Text
Literature Year Text
Literature Vol Text
Literature Pages Text
Patient Name / Initials Text
Patient Patient ID Text
Patient Weight Text
Patient Height Text
Patient GP Record # Text
Patient Specialist Record # Text
Patient Hospital Record # Text
Tasks Created By Text
Task(s) Intake Case # Text
Follow Up Queries Contacted Text
Product Auth. Number Text
Study Registration Registration Number Text
Test Report Result (Value) Text
Study Study Number Text
TestReport TableView Test Result Text
Follow Up Queries Intake Case # Text
Literature Pages Text
Patient Past drug History WHO Dict B Ver Text
References Reference ID Text
Reporter Fax Number Text
Version Information Version Receipt Date Text
Version Information Central Receipt Date Text
Device Information Product Code Text
Device Information Catalog Number Text
Device Information UDI Number Text
Device Information Lot Number Text
Quality Check Return Quantity Text
Product / Lot IdentificationCID Number Text
Product / Lot IdentificationPCID Number Text
Product / Lot IdentificationLot Number Text
Patient Past drug History WHO Drug MPID Text
Parent Past Drug History WHO Drug MPID Text
Parent Past Drug History WHO Dict B Ver Text
Parent Past Drug History MFDS Drug Code Text
Product Substance WHO Substance Code Text
Device Information Software Version Text
Device Information Firmware Version Text
Device Information UDI Production Identifier Text
Device Information Unit of Use UDI-DI Text
Similar Incidents Device Problem Code (In-house) used Text
Product WHO Dict B Ver Text
Product MFDS Drug Code Text
Listedness Event Name (Start Date) Text
General Intake # Text
Listedness eventInternalId Text
Product WHO Drug Code Text
Parent Past Drug History WHO Drug Code Text
Patient Past drug History WHO Drug Code Text
Literature Digital Object Identifier Text
Reporter Postcode Text
Reporter Telephone Text
Patient Patient ID Text
Parent Name / Initials Text
Literature Vol Text
Parent Weight Text
Parent Height Text
Product Substance WHO Dict B Ver Text
Study Center Text
Version Information Intake Number Text
Patient Past drug History WHO Dict C Ver Text
Parent Past Drug History WHO Dict C Ver Text
Product WHO Dict C Ver Text
Product Substance WHO Dict C Ver Text
TestUnits Low Text
Test Low Text
Test High Text
TestUnits High Text
Device Information Basic UDI-DI Text
Quality Check QC Reference Number Text
Device Information UDI Device Identifier Text
Version Information Version Text
Follow Up Queries Contacted Text
Similar Incidents Root Cause Evaluation Code (In-house) used Text
Event Event ID Text
Follow Up Queries Contacted By Text
Follow Up Queries Subject Text
Create Task Case Number Text
Create Task Version Text
Create Task Created By Text
Product Expected Return Quantity Text
Patient BMI (kg/m²) Text
Product Product Code Text
Product Material Name (Number) Text
Follow Up Queries To Text
Email Case Contacted By Text
Product Substance MFDS Substance Code Text
Device Information Serial Number Text
Follow Up Queries Contacted By Text
Device Information Model Number Text
Patient Past drug History MFDS Drug Code Text
Product WHO Drug MPID Text
Patient Randomization # Text
Reporter Reporter ID Text
Literature Literature ID Text
Patient Medical History Medical History ID Text
Parent Medical History Medical History ID Text
Patient Past drug History Past Drug History ID Text
Parent Past Drug History Past Drug History ID Text
Product Product ID Text
Dose Information Dose ID Text
Device Information Device ID Text
Test Report Test ID Text
Product Drug Code Text
Synchronize?
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Test Report Result (Value)
Study Study Number
Reporter Fax Number
Quality Check Return Quantity
Similar Incidents Device Problem Code (In-house) used
Reporter Postcode
Test Low
Test High
Quality Check QC Reference Number
Similar Incidents Root Cause Evaluation Code (In-house) used
Product Expected Return Quantity
Product Substance MFDS Substance Code

Attachments Notes
Device Information Relevant Accessories Used
Device Information Relevant Associated Devices Used
Device Information Remedial actions taken by health care facility, patient or user subsequent to the incident
Device Information General Comments
Device Information Additional Notes
Device Information Nature of Incident
Device Information Additional Manufacturer Narrative
Device Information Malfunction Description
Device Information Brand Name
Device Information Implant Facility
Device Information Explant Facility
Device Information Device Location - Other Text
Device Information Usage - Other Text
Device Information Operator - Other Text
Device Information Remedial Action Initiated - Other Text
Dose Information Additional Notes
Dose Information Dose Description
Dose Information Route (Free Text)
Dose Information Parent Route (Free Text)
Event Additional Notes
Event Reported Event
General Additional Notes
General Report Source (FDA eMDR) - Other Text
IMDRF Coding Investigation Description (Missing IMDRF Code Reason)
IMDRF Coding Device Component Description (Missing IMDRF Code Reason)
IMDRF Coding Device Problem Description (Missing IMDRF Code Reason)
IMDRF Coding Health Impact Description (Missing IMDRF Code Reason)
Literature Additional Notes
Literature Author
Literature Title
Literature Journal
Manufacturer Analysis Preliminary Results and Conclusions
Manufacturer Analysis Initial Actions Implemented
Manufacturer Analysis Further Investigations
Manufacturer Analysis Final (Reportable Incident) Conclusions
Manufacturer Analysis Final (Non-reportable Incident) Conclusions
Manufacturer Analysis Rationale for No Review Required
Manufacturer Analysis Risk Assessment Results
Manufacturer Analysis CAPA, FSCA & Remedial Actions Description
Manufacturer Analysis Time Schedule for Actions Implementation
Manufacturer Analysis Final Comments on Investigations & Conclusions
Manufacturer Analysis No. of events summarized
Neonates Neonatal Notes
Parent Add'l Relevant Medical History
Parent Additional Notes
Parent Medical History Comments
Parent Medical History Additional Notes
Parent Medical History Medical History (Reported)
Parent Name Part(s) Name Part Value
Parent Past Drug History Additional Notes
Parent Past Drug History Drug Indication (Reported)
Parent Past Drug History Drug Name
Parent Past Drug History Drug Reaction (Reported)
Patient Add'l Relevant Medical History
Patient Additional Notes
Patient Gender - Other Text
Patient Medical Institution / Enterprise
Patient Death Cause Cause (Reported)
Patient Medical History Comments
Patient Medical History Additional Notes
Patient Medical History Medical History (Reported)
Patient Name Part(s) Name Part Value
Patient Past drug History Additional Notes
Patient Past drug History Drug Indication (Reported)
Patient Past drug History Drug Name
Patient Past drug History Drug Reaction (Reported)
Pregnancy Information Additional Notes
Pregnancy Information Pregnancy Details
Product Add'l Drug Info Notes
Product Additional Notes
Product Product Name
Product Generic Name
Product Strength (Free Text)
Product Expected Return Quantity
Product Dosage Form (Free Text)
Product Event Relatedness Source (Free Text)
Product Event Relatedness Result (Free Text)
Product Event Relatedness Method (Free Text)
Product Indication Indication (Reported)
Product Name Part(s) Name Part Value
Product Substance MFDS Substance Code
QC Comments Comment Text
Quality Check Additional Notes
Quality Check Return Quantity
Quality Check QC Reference Number
References Notes
Reporter Additional Notes
Reporter Title
Reporter First Name
Reporter Middle Name
Reporter Last Name
Reporter Organization
Reporter Department
Reporter Street Address
Reporter City
Reporter State / Province
Reporter Postcode
Reporter Fax Number
Reporter County
Reporter Street Address 2
Sender Diagnosis Sender's Diagnosis (Reported)
Similar Incidents Other Criteria - Description and Rationale
Similar Incidents Other Criteria (In-house) - Description and Rationale
Similar Incidents Similar Incident Device Variants Description
Similar Incidents Device Variant Counts based on Other Criteria - Description
Similar Incidents Device Problem Code (In-house) used
Similar Incidents Device Problem Term (In-house) used
Similar Incidents Root Cause Evaluation Code (In-house) used
Similar Incidents Root Cause Evaluation Term (In-house) used
Study Study Name
Study Study Number
Study Additional Notes
Study Study Program
Summary Case Narrative
Summary Reporter Comments
Summary Sender Comments
Summary Analysis of Similar Events
Test Additional Notes
Test Result (Value)
Test Comments
Test Test Name
Test Result (Unstructured)
Test Low
Test High
Time Period Analysis Similar Incident Time Period Analysis - Comments
Version Information Version Comments
bsequent to the incident
 SECTION DISPLAY_TEXT
Test Report Result (Value)
Study Study Number
Reporter Fax Number
Quality Check Return Quantity
Similar Incidents Device Problem Code (In-house) used
Reporter Postcode
Test Low
Test High
Quality Check QC Reference Number
Similar Incidents Root Cause Evaluation Code (In-house) used
Product Expected Return Quantity
Product SubstanceMFDS Substance Code