Description of Event or Problem · 1
1ST & SUPERFICIAL 2DN DEGREE BURNS WAS NOTED POST-OP ON PATIENT'S LEFT UPPER ARM & RIGHT FLANK. AREAS THAT WERE PROP WITH TRIADENE PRIOR TO SURGERY. THE PRODUCT IS NEW TO HOPITAL AND THIS IS THE 4TH INCIDENT OF SUCH IN APPROX. 6 WEEKS. PRIOR TO USE OF NEW PRODUCT SUCH REACTIONS WERE EXTREMELY RARE. PRODUCT PULLED FROM SHELVES AND DISTRIBUTOR NOTIFIED OF PROBLEM. DISTRIBUTOR WILL PICK-UP REMAINING STOCK. UNABLE TO DETERMINE TO ANY DEGREE OF CERTAINTY IF PRODUCT WAS DIRECTLY RELATED. PATINETS JHAVE NO HISTORY OF ALLERGIES TO IODINEDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: 4.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: OTHER. RESULTS OF EVALUATION: INVALID DATA, INVALID DATA, INVALID DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, INVALID DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.