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 Number: MW4001952
• MDR Report Key: 106349
• Date Received: 1997-07-18
• Date of Report: 1997-05-27
• Date of Event: 1997-05-24
• Date Added to Maude: 1997-07-21
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ORAFIX SPECIAL
• Generic Name: DENTURE ADHESIVE
• Product Code: KXY
• Date Received: 1997-07-18
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 104569
• Manufacturer: SHEFFIELD LABORATORIES/FARIA
• Manufacturer Address: 170 BROAD ST NEW LONDON CT 06320 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1997-07-18