InjuryDYH
NEOBAND LIGHT CURE BAND CEMENT
Received Jul 29, 2015
Report 2418500-2015-00002 · MDR key 4961222
Device
Generic name
Bracket Adhesive Resin
Manufacturer
Gac InternationalCatalog number
52-800-52
Lot number
4138-07ID1ABCK
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Reaction
Narrative
Description of Event or Problem
IN THIS EVENT A DENTIST REPORTED THAT THEY WERE HAVING ISSUES WITH NEOBAND CEMENT RUNNING OUT OF THE BAND AND IT WENT INTO THE GUMS OF A PATIENT AND CAUSED AN INFECTION.
Additional Manufacturer Narrative
MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, SINCE AN INFECTION WOULD LIKELY RESULT IN THE NEED FOR INTERVENTION, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.