BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 5198163 · Received October 29, 2015

    Report

    Report Number
    8020045-2015-00063
    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. 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 DISTRIBUTOR COMPLAINED THAT "WE'VE HAD ANOTHER COMPLAINT OF ARTIFACTS OCCURRING WITH THE W-60S, WE ADDITIONALLY RECEIVED THE CUSTOMERS RESPONSE: "THE PROBLEM ISN'T (...) THE STICKING, THE PROBLEM IS THE GEL IS HARD AND BLACK ON SOME. THEY ARE DRIED UP". THE DISTRIBUTOR STATED, "NO RISK OR HARM DONE TO THE PATIENT. NO TREATMENT REQUIRED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720828 SKINTACT ECG ELECTRODE DRX LEONHARD LANG GMBH W-60 40325-0153

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK