HUDSON BITE-GARD MOLAR BITE BLOCK

Description of Event or Problem

THE CUSTOMER ALLEGES THAT DURING REMOVAL OF THE BITEGARD, THE HANDLE BROKE OFF INSIDE THE PATIENT'S MOUTH. THE GARD REMAINED IN THE PATIENT'S MOUTH FOR 3 DAYS UNTIL IT WAS REMOVED. INTERVENTION-THE PATIENT HAD TO BE RE-INTUBATED BECAUSE THE PATIENT WAS OBSTRUCTING. NO PATIENT INJURY REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

Additional Manufacturer Narrative

(B)(4). A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT OR A PICTURE OF THE DEFECT WAS NOT PROVIDED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE LACK OF SAMPLE AND SINCE NO LOT NUMBER WAS PROVIDED FOR INVESTIGATION. AN ATTEMPT TO DUPLICATE THE FAILURE MODE WAS MADE BUT AT THE TIME THERE IS NO INVENTORY OF THE INVOLVED PRODUCT CODE AVAILABLE AT THE FACILITY AND IT IS NOT BEING MANUFACTURED AT THE TIME. IF THE SAMPLE BECOMES AVAILABLE AT THIS INVESTIGATION WILL BE UPDATED WITH THE EVALUATION RESULTS.