BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 5198156 · Received October 29, 2015

    Report

    Report Number
    8020045-2015-00062
    Event Type
    Malfunction
    Date Received
    October 29, 2015
    Report Date
    October 29, 2015
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    DRX
    PMA / PMN Number
    K024247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETAINED SAMPLES OF THE COMPLAINED LOT HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. THEY FAILED THE ELECTRICAL TESTS. BOTH GROUPS OF SAMPLES FAILED THE ELECTRICAL TESTS. THE ROOT CAUSE OF THIS DEFECT IS STILL UNDER INVESTIGATION. HOWEVER, IN THE COURSE OF THE INVESTIGATION CONCERNING MDR 8020045-2015-0048, IT WAS RECENTLY DETERMINED THAT SEVERAL MODELS SHARING A CERTAIN DESIGN AND MANUFACTURING PROCESS HAVE A HIGH PROBABILITY TO DEVELOP A DEFECT. WE HAVE THEREFORE DECIDED TO PERFORM A RECALL OF THESE MODELS. BASED ON THIS DETERMINATION WE HAVE REEVALUATED THIS COMPLAINT AND DO NOW BELIEVE IT IS LINKED ALTHOUGH IT WAS NOT INITIALLY OBVIOUS. WE HAVE THEREFORE DECIDED TO REPORT THIS INCIDENT. ANY FURTHER FINDINGS IN THE INVESTIGATION WILL BE REPORTED AS FOLLOW-UP REPORTS TO MDR 8020045-2015-00048 ONLY.

    Description of Event or Problem · 1

    ON (B)(6) 2015, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING ECG ELECTRODES. THE CUSTOMER COMPLAINED THAT LOT CODE 40417-0327 IS LEAVING A LOT OF ARTIFACT. THE DISTRIBUTOR STATED, "NO HARM OR RISK WAS INVOLVED TO THE PATIENT. NO FURTHER TREATMENT WAS NEEDED. ANOTHER LOT NUMBER OF THE W60 WAS USED WITHOUT ANY PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720643 SKINTACT DRX LEONHARD LANG GMBH W-60 40417-0327

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other