3M CLINPRO SEALANT

Description of Event or Problem

DEVICE 2. 3M ESPE WAS RECENTLY NOTIFIED OF AN EVENT THAT OCCURRED APPROXIMATELY 1-1/2 YEARS AGO. ON THE DAY OF THE EVENT, A PEDIATRIC PATIENT VISITED THE REPORTING DENTIST FOR A TREATMENT THAT INVOLVED TWO 3M ESPE PRODUCTS, FILTEK (TM) P60 POSTERIOR RESTORATIVE AND CLINPRO (TM) SEALANT. THE PATIENT LEFT THE OFFICE AND LATER THE SAME DAY WAS SEEN BY A PEDIATRIC DENTIST OR PEDIATRIC PHYSICIAN (DETAILS ON THE TYPE OF PROFESSIONAL ARE NOT AVAILABLE TO 3M ESPE). IT IS REPORTED THAT FOLLOWING A SHOT OF SOME TYPE (DETAILS ON TYPE OF SHOT ARE NOT AVAILABLE TO 3M ESPE), THE PATIENT STOPPED BREATHING AND WENT INTO A COMA, WHERE HE HAS REMAINED FOR THE LAST 1-1/2 YEARS. ADDITIONAL DETAILS ON THIS SITUATION ARE NOT AVAILABLE TO 3M ESPE; BECAUSE OF POTENTIAL AND PENDING LITIGATION, THE DENTIST MAKING THE REPORT TO 3M ESPE WAS NOT WILLING TO PROVIDE ANY ADDITIONAL INFORMATION FOR USE IN THE INVESTIGATION OF THE EVENT.

Additional Manufacturer Narrative

DEVICE NOT RETURNED; THEREFORE, NO EVALUATION WAS CONDUCTED. BOTH 3M ESPE PRODUCTS REPORTED TO HAVE BENE USED IN TREATMENT OF THIS PATIENT HAVE VERY FAVORABLE CLINICAL USE HISTORIES WITHOUT ANY OTHER ALLEGATION OF THIS TYPE. BASED ON THE BIOCOMPATIBILITY ASSESSMENTS OF THESE PRODUCTS ALONG WITH THEIR FAVORABLE USE HISTORY, THIS TYPE OF ADVERSE HEALTH EFFECT IS NOT EXPECTED FROM THE INTENDED USE OF THE PRODUCTS.