BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODPOD

    MDR report key: 7014825 · Received November 9, 2017

    Report

    Report Number
    3008585473-2017-00032
    Event Type
    Malfunction
    Date Received
    November 9, 2017
    Date of Event
    October 5, 2017
    Report Date
    November 9, 2017
    Manufacturer
    HOLLYWOG, LLC
    Product Code
    ITH
    UDI-DI
    00853096004151
    PMA / PMN Number
    K150695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR REVIEW SHOWS THE DEVICE PERFORMED AS INTENDED WHEN IT WAS MANUFACTURED. THE DEVICE WAS EVALUATED. UNABLE TO REPLICATE CUSTOMER'S COMPLAINT, OPERATED TO SPEC. POWER PCB WAS RE-ALIGNED SO THE PORTS AND SWITCH WERE MORE EASILY ACCESSIBLE.

    Description of Event or Problem · 1

    THE DEVICE HAS FULL SCREEN FUNCTIONALITY, BUT WILL NOT PULL AT ALL. HE AND HIS CA HAS TRIED TURNING OFF AND ON THE DEVICE. WHEN ASKED TO CALIBRATE HIS DEVICE, IT WILL NOT BRING HIM TO THE SCREEN TO CALIBRATE. ALSO, THE PATIENT SWITCH WOULD NOT END TREATMENT PREVIOUSLY, SO THE CA IS SENDING BACK THE PATIENT SWITCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794878 MODPOD THERAPEUTIC POWERED TRACTION DEVICE. ITH HOLLYWOG, LLC 12.1000 00853096004151

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability