BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONMED MACROLYTE GROUNDING PAD

    MDR report key: 2590805 · Received May 29, 2012

    Report

    Report Number
    1720159-2012-00047
    Event Type
    Death
    Date Received
    May 29, 2012
    Date of Event
    February 14, 2012
    Report Date
    May 29, 2012
    Manufacturer
    CONMED CORPORATION - CHIHUAHUA
    Product Code
    GEI
    PMA / PMN Number
    K100686
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED WAS NOTIFIED OF THE BURN ON (B)(6) 2012. HOWEVER, CONMED WAS MADE AWARE OF THE DEATH ON (B)(6) 2012. PER A PHONE CONVERSATION WITH THE FACILITY, THE BURN IS BEING DESCRIBED AS '3RD DEGREE', AND THERE WAS A LOT OF SMOKE. THE BURNED AREA HAD TO BE RESECTED AND CLOSED. THE SAMPLE IN QUESTION WAS NOT RETURNED AND AN EVALUATION COULD NOT BE COMPLETED. THE FACILITY DID STATE THE AREA WHERE THE PAD WAS PLACED WAS SHAVED. ALSO, THE FACILITY STATED THE PATIENT HAD OTHER HEALTH ISSUES AND THE POMERANIAN DID NOT DIE DUE TO THE SUSTAINED BURN. THERE IS NO CLEAR INDICATION THAT THIS WAS A MANUFACTURING DEFECT OR THAT THERE WAS ANY PERFORMANCE ISSUES. HOWEVER, AS THE FACILITY DID NOT HAVE SOME INFORMATION THAT CONMED HAD INQUIRED ABOUT, CONMED WAS UNABLE TO CONFIRM THE PRODUCT DID NOT MALFUNCTION. TO BE CONSISTENT AND CONSERVATIVE, CONMED WOULD LIKE TO NOTIFY THE F.D.A. OF THIS INCIDENT. DEVICE NOT RETURNED BY FACILITY.

    Description of Event or Problem · 1

    AT A VETERINARY CLINIC, A CONMED MACROLYTE GROUNDING PAD WAS USED ON THE POMERANIAN. THE POMERANIAN SUSTAINED A BURN AT THE PAD SITE AND HAD DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED MACROLYTE GROUNDING PAD ELECTROSURGICAL DISPERSIVE ELECTRODE GEI CONMED CORPORATION - CHIHUAHUA 1112064

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R AARON 2250 GENERATOR