ORA-FIX *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-02-19 for ORA-FIX * manufactured by Hogil Pharmaceutical Corp.

Event Text Entries

[271781] Consumer opened new container of ora-fix to use it. Consumer had used this product for years and knew that it should look pinkish and creamy, this particular tube was red and sandy. Consumer put it on the dentures and within a few mins consumer began to feel burning of eyes and throat, and feeling peculiar, the product gave consumer a severe sore throat. Consumer tried to wash it off it took consumer 15 mins to do so, and consumer noted that the ora-fix had eaten away at the dentures and it was stuck to the roof of mouth. Now consumer noted that the stuff is eating away at the actual container. Consumer returned the product to store where consumer had purchased it. Then called the mfr consumer line. Spoke to rep and was told to return the tube and their insurance dept would get in touch with consumer. Consumer went to store and retrieved the tube of ora-fix and has it at home. Consumer also has purchased a new tube with different lot number (# 80615" wich is using now with old denture, because the new ones consumer have been damaged by the tube of ora-fix in question. Consumer received severe burning of mouth watery eyes, and sore throat.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003229
• MDR Report Key: 384305
• Date Received: 2002-03-19
• Date Added to Maude: 2002-03-27
• 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: ORA-FIX
• Generic Name: DENTURE ADHESIVE
• Product Code: KOQ
• Date Received: 2002-02-19
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 373357
• Manufacturer: HOGIL PHARMACEUTICAL CORP
• Manufacturer Address: 2 MANHATTANVILLE RD PURCHASE NY 10577 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-03-19