BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKINTACT

    MDR report key: 4898333 · Received July 1, 2015

    Report

    Report Number
    8020045-2015-00048
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Report Date
    July 1, 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 AND RETURNED SAMPLES OF THE COMPLAINED LOT HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. THE RETAINED ELECTRODES AS WELL AS THE RETURNED SAMPLES FAILED THE ELECTRICAL TESTS. THE ROOT CAUSE OF THIS DEFECT HAS NOT BEEN FULLY IDENTIFIED YET. HOWEVER, IN THE COURSE OF THE INVESTIGATION, IT WAS 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. WE WILL PROVIDE FURTHER FINDINGS AND CONCLUSIONS FROM THE INVESTIGATION IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    THE RETAINED AND RETURNED SAMPLES (REC'D TWO DAYS AGO) OF THE COMPLAINED LOT HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. THE RETAINED ELECTRODES AS WELL AS THE RETURNED SAMPLES FAILED THE ELECTRICAL TESTS. THE ROOT CAUSE AND THE EXTENT OF THIS DEFECT BEYOND THE INVOLVED LOT ARE STILL UNDER INVESTIGATION. WE ARE FILING THIS REPORT BECAUSE A CONNECTION WITH THE MALFUNCTION REPORTED UNDER 8020045-2015-00022 MIGHT BE POSSIBLE. WE WILL PROVIDE A FOLLOW-UP REPORT WITH OUR FINDINGS AND FURTHER CONCLUSIONS.

    Description of Event or Problem · 1

    ON (B)(6), 2015, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING ECG ELECTRODES. THE CUSTOMER COMPLAINED THAT SKINTACT W-60 ECG ELECTRODES HAD BECOME INCOMPATIBLE WITH THEIR MEDICAL DEVICE, A PAIN THERAPY SYSTEM. INVESTIGATING THE COMPLAINT, OUR DISTRIBUTOR (B)(4) REPORTED THAT ALSO ANOTHER CUSTOMER HAD ISSUES WITH THE SAME LOT NUMBER OF THIS ELECTRODE MODEL "NOT WORKING CORRECTLY". THE DISTRIBUTOR STATED, "NO PATIENT WAS HARMED OR AT RISK WITH THE ELECTRODE NOT WORKING PROPERLY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426587 SKINTACT ECG ELECTRODE DRX LEONHARD LANG GMBH W-60 40304-0324

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other