BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DR COMFORT

    MDR report key: 7654934 · Received July 2, 2018

    Report

    Report Number
    3008579854-2018-00006
    Event Type
    Injury
    Date Received
    July 2, 2018
    Date of Event
    June 25, 2018
    Report Date
    July 2, 2018
    Manufacturer
    DR COMFORT, A DJO, LLC COMPANY
    Product Code
    KYS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    COMPLAINT RECEIVED THAT ALLEGES "GLUE HAS COME OFF THE TOP COVER THAT CAUSED SERIOUS INJURY. CREATED ULCER ON THE SOLE OF PTS FOOT LIKE A SILVER DOLLAR SIZE THAT MAY CAUSE AMPUTATION TO THE PT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498661 DR COMFORT L5000 TMA TOE FILLER CUSTOM INSOLE KYS DR COMFORT, A DJO, LLC COMPANY 12-3123-0-50000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other