Description of Event or Problem · 1
PATIENT RECEIVED A TREATMRNT OF IONTOPHORES ON 5/25/93 TO HER LEFT ARM. ON 5/27/93 SHE RETURNED TO THE REHAB CLINIC WITH A WOUND TO THE VENTRAL ASPECT OF HER ARM WHERE SHE RECEIVED THE IONOTOPHORESIS. TEH WOUND WAS APPROXIMATELY ONE (1) INCH IN DIAMETER AND HAD A WELL FORMED SCAB OVER IT. IT WAS SURROUNDED BY SOME RED AREA - NO PUS OR DRAINAGE NOTED. PATIENT STATED AT THE TIME SHE WAS RECEIVING THE IONTOPHORESIS THAT IT FELT THE SAME AS ALWAYS AND SHE DID NOT NOTE ANYTHING DIFFERENT. PATIENT CONTINUED AND EXTENSION FOR BOTH WRISTS INA PASSIVE MODE WITH HER RESISTING ECCENTRICALLY. SHE CONTINUES TO BE MUCH IMPROVED AND WOUND AREA ON THE VENTRALASPECT ON HER LEFT ARM IS HEALINGDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.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: NO DATA. RESULTS OF EVALUATION: NO 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, USER EDUCATION PROVIDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.