BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIAB

    MDR report key: 1021169 · Received March 27, 2008

    Report

    Report Number
    8020045-2008-00004
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 19, 2008
    Report Date
    March 25, 2008
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    PMA / PMN Number
    K030362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE DEVICE INVOLVED HAS BEEN DISCARDED BY THE USER, ONLY A SAMPLE FROM THE SAME LOT HAS BEEN RECEIVED. THE RETAINED SAMPLES OF THE SAME LOT AND THE RECEIVED ONE HAVE BEEN TESTED THERMALLY, ELECTRICALLY, FOR THEIR ADHESION AND INSPECTED VISUALLY. ALL SAMPLES WERE FOUND TO PERFORM WITHIN THE LIMITS AND NO FAULTS COULD BE DETECTED. A PHOTO OF THE INJURY HAS ALSO BEEN RECEIVED. IT SHOWS THE LEFT UPPER THIGH, WITH FIVE BURN MARKS. THE THIGH AND THE AREA OF THE BURNS IN PARTICULAR ARE VERY HAIRY. THE HAIR INDICATES THAT THE IFU HAS NOT BEEN FOLLOWED. THE IFU STATES EXPLICITLY "SHAVE, DEGREASE AND DRY THE SELECTED SURFACE." THIS FAILURE OF THE USER TO FOLLOW INSTRUCTIONS HAS AT LEAST CONTRIBUTED TO BUT MOST PROBABLY CAUSED THE EVENT. WE ASSUME THAT THE EXCESSIVE HAIR LEFT AT THE PLACEMENT SITE HAS IMPEDED FULL CONTACT OF THE GEL WITH THE SKIN OR EVEN SERVED AS A PREFERENTIAL RETURN PATH FOR THE CURRENT, THUS CREATED LOCAL HOT SPOTS AND EVENTUALLY LED TO THE BURNS.

    Description of Event or Problem · 1

    AN ELECTROSURGICAL PROCEDURE WAS PERFORMED AT HOSP. THE PROCEDURE WAS A "RF CARDIAC ABLATION," A STOCKERT GENERATOR AND A DISPERSIVE UNSPLIT ELECTRODE HAVE BEEN USED. THE ELECTRODE WAS APPLIED ON THE UPPER LEFT THIGH. THE THIGH WAS HAIRY, NO SKIN PREPARATION OR SHAVING WAS PERFORMED. THE GENERATOR HAD BEEN SET ON 30W, THE OUTPUT HAD NOT BEEN INCREASED DURING THE PROCEDURE, THE DURATION OF WHICH HAS NOT BEEN SPECIFIED. THE MORNING AFTER THE PROCEDURE FIVE BLISTERS INDICATING BURNS WERE DISCOVERED ON THE LEFT THIGH IN THE AREA WHERE THE PLATE HAD BEEN APPLIED ( 2 OF APP. 1 SQCM SIZE, 3 SMALLER ONES). THE PT HAD A "PHARMACOLOGICAL TREATMENT," NO SPECIFIC WOUND TREATMENT HAS BEEN REPORTED. THE PT IS SLIM, OF NORMAL SKIN TYPE, VERY HAIRY. THE DISPERSIVE ELECTRODE WAS REPORTED TO HAVE ADHERED WELL, NO RESIDUES OF GEL WERE OBSERVED ON THE SKIN UPON THE REMOVAL OF THE ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIAB GROUNDING PLATE GEI LEONHARD LANG GMBH RS61B 71025-0742

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other