BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACK BRACE

    MDR report key: 7637915 · Received June 25, 2018

    Report

    Report Number
    MW5078063
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    May 15, 2018
    Report Date
    June 22, 2018
    Manufacturer
    OPTIMA MANUFACTURING, LLC.
    Product Code
    PMV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(6) CHARGED ME AND INSURANCE (B)(6) FOR A MEASLY BACK BRACE. THIS IS AN OVER CHARGE AND THEY WON'T RETURN IT. IT ISN'T EVEN OF GOOD QUALITY AND THEY WON'T TAKE IT BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475128 BACK BRACE ORTHOSIS LIMB FOR BACK PAIN PMV OPTIMA MANUFACTURING, LLC. L0650

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other