BITE BLOCK - MAXI - LATEX FREE STRAP
Received Feb 6, 2015
Report 1528319-2015-00002 · MDR key 4508286
Device
Generic name
Bite Block
Manufacturer
United States Endoscopy Group, Inc.Model number
00712804Catalog number
00712804
Lot number
UNK
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Skin Tears
Narrative
Description of Event or Problem
THE USER REPORTED THREE PTS WERE AFFECTED BY CUTS TO THE LIP AFTER ENDOSCOPY PROCEDURES WHICH INCLUDED USE OF BITE BLOCK - MAXI - LATEX FREE STRAP ((B)(4)). THESE EVENTS OCCURRED OVER THE COURSE OF A NUMBER OF MONTHS, AND THE PTS WERE TREATED WITH ANTIBIOTIC OINTMENT. THE USER STATED THE BITE BLOCK WAS NOT THE KNOWN CAUSE OF THE CUTS TO THE LIP, AND STATED THE CONDITION MAY INSTEAD HAVE BEEN THE RESULT OF FACTORS SUCH AS SEDATION LEVEL, CARE AND SKILL OF THE PERSON INSERTING THE BLOCK, AND THE CONDITION OF THE LIPS PRIOR TO THE PROCEDURE.
Additional Manufacturer Narrative
THE PRODUCT WAS NOT RETURNED AND LOT NUMBERS WERE NOT PROVIDED, CONSEQUENTLY THERE WAS NO EXAMINATION OF THE PRODUCT AND NO REVIEW OF THE MFG RECORD. A REVIEW OF COMPLAINT HISTORY FINDS NO SIMILAR REPORT OF CUTS TO THE LIP ASSOCIATED WITH THIS PRODUCT. THE REPORT WILL BE UPDATED IF FURTHER INFO BECOMES AVAILABLE.