ORAFIX SPECIAL *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-18 for ORAFIX SPECIAL * manufactured by Sheffield Laboratories/faria.

Event Text Entries

[69320] Purchased product for wife. After applying product to denture, pt put the dentures in her mouth. They immediately began to "sting/burn" her gums. She removed the dentures, rinsed both her gums and the dentures. No doctor or hospitalization required.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4001952
MDR Report Key106349
Date Received1997-07-18
Date of Report1997-05-27
Date of Event1997-05-24
Date Added to Maude1997-07-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameORAFIX SPECIAL
Generic NameDENTURE ADHESIVE
Product CodeKXY
Date Received1997-07-18
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key104569
ManufacturerSHEFFIELD LABORATORIES/FARIA
Manufacturer Address170 BROAD ST NEW LONDON CT 06320 US


Patients

Patient NumberTreatmentOutcomeDate
10 1997-07-18

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