BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINTACT

    MDR report key: 4058980 · Received August 20, 2014

    Report

    Report Number
    8020045-2014-00009
    Event Type
    Injury
    Date Received
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    PMA / PMN Number
    K030362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY, THERMALLY AND MECHANICALLY. ALL SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. AS NO FURTHER INFORMATION HAS BEEN PROVIDED TO US DESPITE REPEATED REQUESTS, IT IS NOT POSSIBLE TO CONDUCT ANY FURTHER ANALYSIS. WE ACTUALLY DO NOT KNOWN FOR SURE IF THIS INCIDENT IS REPORTABLE AS THE ONLY AVAILABLE DESCRIPTION WAS "LIGHT BURNS". WE WILL CONTINUE TO ASK FOR FURTHER INFORMATION AND WILL RELAY ANY INFORMATION AND FURTHER CONCLUSIONS IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ON (B)(6), WE HAVE BEEN INFORMED BY (B)(6) ABOUT A SKIN BURN. AT (B)(6), A SURGICAL PROCEDURE WAS PERFORMED. THE HOSPITAL REPORTED THAT "LIGHT BURNS" OCCURRED IN CONNECTION WITH AN ELECTROSURGICAL DISPERSIVE GROUNDING PLATE (MODEL SKINTACT RS21). NO FURTHER INFORMATION ON THE PATIENT, THE GENERATOR MODEL, THE POWER SETTINGS, THE PATIENT INJURY, ITS PRECISE LOCATION AND THE TREATMENT HAVE BEEN DISCLOSED SO FAR DESPITE OF REPEATED REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502456 SKINTACT ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH RS21 30221-0808

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other