Description of Event or Problem · 1
"ON OR ABOUT 2005, UNDER THE SUPERVISION OF DEFENDANTS AND WHILE WEARING DEFENDANT'S MONITORING DEVICE, WHICH INCLUDED THREE (3) ELECTRODES ON HIS CHEST AND ABDOMEN, PLAINTIFF AWOKE FROM SLEEPING AND IMMEDIATELY NOTICED HAVING SUSTAINED SEVERE BURNS TO HIS SKIN IN THE EXACT PLACE WHERE EACH ELECTRODE HAD BEEN PREVIOUSLY APPLIED. PLAINTIFF IMMEDIATELY SOUGHT MEDICAL TREATMENT FOR THE BURNS FROM THE MEDICAL CENTER AND WAS DIAGNOSED WITH SECOND DEGREE BURNS - CHEMICAL OVER HIS CHEST AND ABDOMEN. AS A RESULT OF THE SECOND DEGREE BURNS TO HIS BODY, PLAINTIFF NOW HAS UNSIGHTLY, PERMANENT DISCOLORATION IN THREE CIRCULAR AREAS ON THIS [SIC] CHEST AND ABDOMEN AS A RESULT OF WEARING THE MONITORING DEVICE AND HAS NOT RECOVERED FROM THIS INJURY." THE ECG ELECTRODES IN QUESTION WERE MANUFACTURED BY CONMED CORPORATION, AND SENT TO DISTRIBUTOR WHO, IN TURN DISTRIBUTED THE ELECTRODES IN THEIR ORIGINAL PACKAGING TO FOR USE IN A CLINICAL STUDY UNDER THE SUPERVISION OF HEALTH PROFESSIONALS. IN ACCORDANCE WITH DISTRIBUTOR'S PROCEDURE FOR SINGLE USE ITEMS, NO USED ELECTRODES WERE RETURNED FROM THIS STUDY AND WE HAVE THEREFORE NOT BEEN ABLE TO EXAMINE THEM OR RETURN THEM TO THE DEVICE MANUFACTURER. THE SUIT DOES NOT CLAIM THE SUBJECT WAS HOSPITALIZED. DISTRIBUTOR IS NOT THE MANUFACTURER OF THE ECG ELECTRODES, HOWEVER WE ARE REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803. THE ECG ELECTRODES AND LIFESHIRT SYSTEMS USED IN THE STUDY WERE DELIVERED IN ACCORDANCE WITH APPROVED SYSTEM SPECIFICATIONS. ALL CONMED ELECTRODES RECEIVED AT DISTRIBUTOR ARE SUBJECT TO A RECEIVING INSPECTION PROCEDURE TO CONFIRM CERTIFICATE OF CONFORMITY. AS PART OF ORIGINAL 510(K) FILING (K031550), DISTRIBUTOR CONTRACTED ANOTHER COMPANY TO PREPARE A THIRD-PARTY SAFETY RISK ANALYSIS FOR THE LIFESHIRT SYSTEM. THE ANALYSIS INCLUDED AN ASSESSMENT OF THE RISK OF A USER BEING BURNED DUE TO A SHORT CIRCUIT CAUSING RAPID BATTERY DISCHARGE. THE ANALYSIS CONFIRMED COMPLIANCE. THE RISK PROBABILITY WAS DETERMINED TO BE "OCCASIONAL" AND THE RISK SEVERITY WAS DETERMINED TO BE "NEGLIGIBLE." DISTRIBUTOR DID NOT RECEIVE NOTICE OF THIS EVENT AT THE TIME IT WAS ALLEGED TO HAVE OCCURRED. THE HELPDESK LOG SHOWS NO RECORD OF ANY CONTACT ABOUT THIS EVENT, NOR HAS ANY SIMILAR EVENT BEEN REPORTED BY ANYONE AT ANY TIME. DISTRIBUTOR HAS NOT BEEN ABLE TO CONFIRM THE VALIDITY OF THE CLAIMS IN THE ABOVE SUIT. DISTRIBUTOR WILL CONTINUE TO INVESTIGATE THIS EVENT AND WILL UPDATE THE FDA AS ANY NEW INFORMATION BECOMES AVAILABLE.