InjuryKXY
ORAFIX SPECIAL
Received Jul 18, 1997 · Event occurred May 24, 1997
Report MW4001952 · MDR key 106349
Device
Generic name
Denture Adhesive
Manufacturer
Sheffield Laboratories/fariaModel number
*Catalog number
*
Lot number
*
Product problems
- Reaction
Patient
*
- Pain
- Burning Sensation
Narrative
Description of Event or Problem
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.