BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIGEN RADIOFREQUENCY GENERATOR

    MDR report key: 2757645 · Received September 18, 2012

    Report

    Report Number
    1811755-2012-03547
    Event Type
    Injury
    Date Received
    September 18, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 11, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GXD
    PMA / PMN Number
    K071482
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED AT THE MFR FOR TESTING. AN EVAL WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A F/U REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS BURNED TWICE ON THE EXTERNAL SIDE OF THE THIGH DURING THE POST-OPERATIVE PERIOD OF THERMOREGULATION. THE BURN WAS AT LEAST A 2ND DEGREE BURN AND WAS DESCRIBED AS THE SIZE OF 2 EURO COINS. THERE WAS NO SPECIFIC MEDICAL INTERVENTION, THE PT HAS A BANDAGE AND HEALING CREAM TO TREAT THE BURNS. THE PT HAS NO PERMANENT IMPAIRMENT. THE CUSTOMER DID NOT USE THE SELF-ADHESIVE ELECTRODE WHICH WERE PROVIDED WITH THE GENERATOR, BUT INSTEAD USED SELF-ADHESIVE ELECTRODES FROM A COMPETITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIGEN RADIOFREQUENCY GENERATOR GXD STRYKER INSTRUMENTS KALAMAZOO LES5611

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other