BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINTACT

    MDR report key: 3779193 · Received April 17, 2014

    Report

    Report Number
    8020045-2014-00006
    Event Type
    Injury
    Date Received
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    PMA / PMN Number
    K072233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETAINED SAMPLES HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. MECHANICAL TEST WERE PERFORMED ON 2 RETAINED SAMPLES. ALL SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. AS NO FURTHER INFO HAS BEEN PROVIDED TO US DESPITE REPEATED REQUESTS, IT REMAINS UNCLEAR WHETHER THE DEFIBRILLATION ELECTRODE SET OR OTHER INFLUENCES HAVE BEEN RESPONSIBLE FOR THE INCIDENT. WE WILL CONTINUE TO ASK FOR FURTHER INFO. WE WILL RELAY ANY FURTHER INFO AND CONCLUSIONS IN A F/U REPORT.

    Description of Event or Problem · 1

    ON (B)(6), WE HAVE BEEN INFORMED BY (B)(6) ABOUT AND INCIDENT WITH A DEFIBRILLATOR ELECTRODE SET AT (B)(6) HOSPITAL. THE DEFIBRILLATION ELECTRODE SET (SKINTACT DF27N) WAS CONNECTED WITH A PHILIPS DEFIBRILLATOR (MODEL UNK). THE INITIAL REPORT DISCLOSED THE FOLLOWING INFO: "(...) THREE TIMES THEY USED THE PADS (DF-27) WITH THEIR PHILIPS MACHINE IN THE ICU DEPT WHEN THEY NOTICED THAT THE PADS CAUSED BURN TO THE PT. THE CUSTOMER TOLD ALSO THAT IT SMELLS LIKE BURNING THE PADS ITSELF (...)." NO FURTHER INFO ON THE PT, THE PROCEDURE, THE DEFIBRILLATOR MODEL, THE SKIN PREPARATION, AND THE INJURY HAVE BEEN DISCLOSED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236407 SKINTACT MULTIFUNCTIONAL DEFIBRILLATION ELECT MKJ LEONHARD LANG GMBH DF27N 30323-0770

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other