InjuryEBC
FUJI PLUS CONDITIONER
Received Jul 10, 1998 · Event occurred Jun 3, 1998
Report 1410097-1998-00002 · MDR key 176214
Device
Generic name
Tooth Surface Conditioner
Manufacturer
Gc America, Inc.Model number
UNKCatalog number
433125
Lot number
261171
Product problems
- Thermal Decomposition of Device
- Unknown (for use when the device problem is not known)
- Device Rinsing Issue
Patient
47 YR
- Erythema
- Inflammation
- Burning Sensation
- Contamination, chemical
- Hospitalization required
Narrative
Description of Event or Problem
DR WAS CEMENTING A CROWN WITH FUJI PLUS CEMENT. AFTER PLACING THE FUJI PLUS CONDITIONER ON TOOTH, THE PT PLACED TONGUE ON THE TOOTH AND EXPERIENCED A BITTER TASTE. SHE RETURNED TO DENTAL OFFICE LATER COMPLAINING OF REDNESS AND BURNING ON TONGUE, GUM TISSUE AND THROAT. BURNING SENSATION CONTINUED INTO THE EVENING HOURS. PT WENT TO ER ROOM AND WAS TREATED FOR A CHEMICAL BURN.