BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOTECH PRODUCTS LLC

    MDR report key: 7870587 · Received September 12, 2018

    Report

    Report Number
    2025917-2018-00111
    Event Type
    Malfunction
    Date Received
    September 12, 2018
    Date of Event
    July 30, 2018
    Report Date
    September 12, 2018
    Manufacturer
    NEOTECH PRODUCTS LLC
    Product Code
    CBH
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VELCRO HOOK OF RETURNED DEVICE WAS SEPARATED. PER OUR INVESTIGATION THIS HAS MOST LIKELY HAPPENED BECAUSE OF ABNORMALITY ON ONE OF THE WELDING PARAMETERS. RETAIN SAMPLES WERE ALSO INSPECTED AND NO FAILURE OR ABNORMALITY WAS OBSERVED. COMPLAINT COULD NOT BE REPRODUCED ON SAMPLE DEVICES AND THEY FUNCTION NORMAL AS INTENDED. PER COMPLAINT RATIO CALCULATION THE INCIDENT SEEMS TO BE VERY RARE TO HAPPEN. THE RATIO OF (B)(4) REPRESENTING A NEGLIGIBLE RISK FROM THIS DEVICE. THIS COMPLAINT WILL BE MONITORED FOR TRENDING PURPOSES AND IS ADDED TO THE RELATED LOGS AND CHARTS.

    Description of Event or Problem · 1

    CUSTOMER OPENED A NEW PART ABOUT 6 PM AND USED ON HER SON. THE NEXT MORNING SHE REALIZED THAT IT WAS DETACHED. SHE CHANGED THAT WITH ANOTHER ONE, THERE WAS NO ADVERSE EVENT AND SHE REPORTED THE EVENT TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708521 NEOTECH PRODUCTS LLC EZCARE SOFTOUCH CBH NEOTECH PRODUCTS LLC N926 2018-0492

    Patients

    Seq Age Sex Outcome Treatment
    1