TOOTH CONDITIONER PKG

Additional Manufacturer Narrative

AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AS EVIDENCED BY PREVIOUS REPORTED EVENTS WITH SIMILAR FILES. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT TOOTH CONDITIONER WAS DISPENSED EXCESSIVELY IN A PATIENT'S MOUTH COVERING PALLET AND THROAT. THE TOOTH CONDITIONER WAS RINSED THOROUGHLY. PATIENT CONSULTED PHARMACY AND THEY RECOMMENDED BENADRYL AND MAALOX. MATERIAL LEFT OVER WAS THROWN AWAY. FURTHER INFORMATION REQUESTED.

Additional Manufacturer Narrative

PRODUCT NOT RECEIVED AT INVESTIGATION SITE AND THE LOT# IS UNKNOWN. THEREFORE A DHR CANNOT BE DONE. COMPLAINT WILL BE REOPENED IF SUSPECT PRODUCT OR INVESTIGATION RESULT ARRIVES PER (B)(4).