PERFORMAVE

Description of Event or Problem

PATIENT RECEIVED IONTOPHORESIS TREATMENT TO R ARM 11/09/07. THE MEDICATION USED WITH THE THERAPY WAS DEXAMETHAZONE 4MG/ML. THE SKIN WAS PREPPED PER MANUFACTURING RECOMMENDATION. CLEANED UNDER BOTH DISPERSIVE AND TREATMENT SITES WITH THE SUPPLIED ALCOHOL PREP PAD, AND ALLOWED TO DRY. THE SETTINGS USED WERE 80MA AT 4.0 CURRENT. WHEN DISPOSABLE PAD WAS REMOVED A QUARTER SIZED BURN WAS NOTED. PT SUBSEQUENTLY DEVELOPED A BLISTER FOLLOWED BY DARK GREEN SCAB FORMATION. THE AREA REQUIRED SHARP DEBRIDEMENT ON 11/17/07 AND TREATMENT WITH ACCUZYME. CLINICAL ENGINEERING DEPARTMENT ASSESSED THE MACHINE AND DID NOT IDENTIFY A MALFUNCTION. ONE OF TWO RECENT INCIDENTS. UNKNOWN LOT NUMBER, DEVICE AND PACKAGING WAS NOT SAVED. THE MACHINE WAS RETURNED TO THE COMPANY THROUGH THE SALES REP AND ALL OF THE CURRENT STOCK OF ELECTRODES WAS SWITCHED OUT.