BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYHESIVE PATIENT RETURN ELECTRODE

    MDR report key: 2946236 · Received February 6, 2013

    Report

    Report Number
    3005099803-2013-00511
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEI
    PMA / PMN Number
    K822572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER'S NUMBER IS UNKNOWN. THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF SIX COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2013-00508 ADDRESSES THE LEVEEN PROBE, MANUFACTURER REPORT # 3005099803-2013-00509 ADDRESSES THE RF3000 RADIOFREQUENCY GENERATOR, WHILE MANUFACTURER REPORT # 3005099803-2013-00510, MANUFACTURER REPORT # 3005099803-2013-00511, MANUFACTURER REPORT # 3005099803-2013-00512, MANUFACTURER REPORT # 3005099803-2013-00513 ADDRESSES THE FOUR POLYHESIVE PATIENT RETURN ELECTRODES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 AN RF3000 RADIOFREQUENCY GENERATOR, FOUR POLYHESIVE PATIENT RETURN ELECTRODES, AND A LEVEEN STANDARD ELECTRODE WERE USED DURING A HEPATIC RADIOFREQUENCY ABLATION (RFA) IN THE LIVER PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT; HOWEVER FOLLOWING THE PROCEDURE THE RADIOGRAPHER NOTED REDNESS. IN THE RECOVERY ROOM, THE PATIENT COMPLAINED OF THIGH PAIN AND A PHYSICIAN FOUND SECOND DEGREE BURNS ON THE SURFACE OF THE INNER SIDES OF THE THIGHS. HE ALSO NOTED REDNESS CAUSED BY MINOR BURN ON THE OUTER THIGHS. THE PHYSICIAN PRESCRIBED A JELONET AND DRY DRESSINGS FOR THE INNER SIDES AND BIAFINE FOR THE OUTER THIGHS. IT WAS CONFIRMED THAT THE PATIENT WAS NOT HOSPITALIZED FOR A LONGER PERIOD OF TIME DUE TO THE BURNS. THE PATIENT WAS TREATED FOR THE BURNS AND NO LONGER SUFFERS ANY PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51054 POLYHESIVE PATIENT RETURN ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - MARLBOROUGH M001262191

    Patients

    Seq Age Sex Outcome Treatment
    1 Other