STYLUS EASYCARE

Description of Event or Problem

A PT WAS BURNED AFTER COMING INTO CONTACT WITH A HANDPIECE WHICH REPORTEDLY OVERHEATED. NO BLISTER OR MARKING WAS PRESENT AND NO MEDICAL TREATMENT WAS REQUIRED.

Additional Manufacturer Narrative

IN THIS EVENT A DOCTOR REPORTED THAT A PT WAS BURNED AFTER COMING INTO CONTACT WITH A HANDPIECE WHICH REPORTEDLY OVERHEATED. THOUGH NO MEDICAL INTERVENTION WAS REQUIRED TO TREAT THE BURN IN THIS EVENT, THERE HAVE BEEN PREVIOUSLY REPORTED EVENTS INVOLVING SIMILAR DEVICES THAT RESULTED IN THE NEED FOR MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. CONSEQUENTLY, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION IS LIKLEY TO RESULT IN A SERIOUS INJURY. THE DEVICE WAS REPAIRED AND RETURNED PRIOR TO RECEIVING INFORMATION THAT MADE THIS EVENT REPORTABLE. HOWEVER, THE REPAIR NOTES INDICATE THAT THE CAP WAS STUCK IN THE DOWNED POSITION AND THE PUSHER WAS DRILLING THROUGH THE CAP. ADDITIONALLY, A DHR REVIEW WAS CONDUCTED FOR THE LOT INVOLVED IN THIS EVENT AS WELL AS THE LOTS MANUFACTURED IMMEDIATELY PRIOR AND SUBSEQUENT TO THIS LOT; NO ABNORMALITIES WERE NOTED.