POST A THERMITIGHT ABDOMINAL CASE, A BURN WAS DISCOVERED BY THE RN AFTER REMOVING THE GROUNDING PAD. A REDDENED AND RAISED AREA WAS NOTICED IN THE MID GROUNDING PAD AREA. THE MD WAS NOTIFIED. BACITRACIN AND A TELFA DRESSING WERE APPLIED. PATIENT WAS PUT ON KEFLEX 500MG TID AND INSTRUCTED TO WATCH FOR SIGNS OF INFECTION. MD RESPONDED ON (B)(6) 2015 AND CONFIRMED THE SKIN WAS BLISTERED AND BROKEN. NO INFECTION REPORTED, PATIENT REPORTED NO PAIN. PATIENT WAS TREATED CONSERVATIVELY WITH SILVADENE. ON (B)(6) 2015, THE MD E-MAILED THAT THE INJURY HAD PROGRESSED TO A FULL THICKNESS BURN. ON (B)(6) 2015 THE MD CONFIRMED VIA EMAIL PATIENT (B)(6) HAS A 3RD DEGREE BURN, WITH NO INFECTION, AND IS CONTINUING TREATMENT WITH SILVADENE. WOUND IS PROGRESSIVELY HEALING.
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Patient 1
THE RESULTS OF THE INVESTIGATION CONCLUDED THAT THE DEVICE FUNCTIONED AS INTENDED DURING A SIMULATED LESION TEST. THE PRESENCE OF A HAIR-LIKE FOREIGN MATERIAL ON THE GROUNDING PAD, IN ADDITION TO THE EVENT DESCRIPTION, IS CONSISTENT WITH PLACEMENT OF THE GROUNDING PAD OVER HAIR. THE RF DISPOSABLE GROUNDING PAD INSTRUCTIONS FOR USE (IFU) WARNS "AVOID PLACEMENT OVER SCARS, BONY PROMINENCES, PROSTHESIS HAIR OR ECG ELECTRODES. FAILURE TO ACHIEVE GOOD SKIN CONTACT BY THE ENTIRE SURFACE OF THE GROUNDING PAD MAY RESULT IN SIGNIFICANT ELECTROSURGICAL BURNS AT THE PAD LOCATION". A REVIEW OF INSPECTION RESULTS FOR THIS LOT NUMBER CONFIRMED THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE CAUSE OF THE REPORTED EVENT IS CONSISTENT WITH IMPROPER PLACEMENT OF THE GROUNDING PAD.