BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINTACT

    MDR report key: 1672801 · Received April 29, 2010

    Report

    Report Number
    8020045-2010-00007
    Event Type
    Injury
    Date Received
    April 29, 2010
    Report Date
    April 22, 2010
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    ODR
    PMA / PMN Number
    K063161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE INCIDENT AND 4 OTHER ELECTRODES WERE RETURNED IN THEIR ORIGINAL POUCH. THE DEVICE INVOLVED, TWO OF THE RETURNED SAMPLES OF THE SAME LOT AND RETAINED SAMPLES OF THE SAME LOT HAVE BEEN TESTED VISUALLY, ELECTRICALLY, AND THERMALLY. MECHANICAL TEST WAS PERFORMED ON 2 RETURNED AND ON 2 RETAINED SAMPLES (THE DEVICE INVOLVED IN THE INCIDENT WAS IN A STATE NOT SUITABLE FOR THE MECHANICAL TEST). ALL DEVICES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. THE INVOLVED ELECTRODE SHOWS NO STAINS OR MARKS THAT WOULD INDICATE A BURN. WE ARE THEREFORE, NOT SURE, WHETHER THIS INCIDENT IS REPORTABLE AT ALL. NO CONCLUSION CAN BE DRAWN SO FAR. WE WILL CONTINUE TO ASK FOR FURTHER INFO AND WILL RELAY SUCH INFO AND ANY CONCLUSION IN A F/U REPORT.

    Description of Event or Problem · 1

    ON 03/25, WE HAVE BEEN INFORMED ABOUT AN INJURY OF A PT AT A HOSPITAL IN (B) (6). THE DATE AND NATURE OF THE SURGERY ARE STILL UNK TO US. A NON-MONITORING DISPERSIVE ELECTRODE (MODEL WR01) AND A ELECTROSURGICAL GENERATOR (NO MODEL HAS BEEN REVEALED) WERE USED. NO INFO OF THE SIZE AND THE DEGREE OF THE BURN, HOW IT WAS TREATED AFTERWARDS, HOW THE SKIN WAS PREPARED, THE ORIENTATION OF THE ELECTRODE, THE GENERATOR MODEL, THE POWER SETTING USED COULD BE OBTAINED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKINTACT ELECTROSURGICAL GROUNDING PLATE ODR LEONHARD LANG GMBH WR01 80408-0803

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other