BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHEELCHAIR COMPONENTS

    MDR report key: 3022198 · Received March 26, 2013

    Report

    Report Number
    1525712-2013-02332
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    UNKNOWN
    Product Code
    KNN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER ORDER (B)(4) THE DEALER STATES THIS WAS PLACED ON A QUICKIE CHAIR WITH THE BACK PURCHASED THROUGH PINDOT AND THE LATERALS WERE TOO WEAK OF A MATERIAL FOR THE PERSON USING THE CHAIR...HE SAID IT'S AN (B)(6) GIRL WITH CEREBRAL PALSY WHO MAKES SUDDEN MOVEMENTS AND THE PLASTIC WASN'T DURABLE ENOUGH FOR HER. I EXPLAINED WE CAN RETURN IT AND IT WILL BE INSPECTED AND IF IT'S DEEMED ABUSE OR NOT A MANUFACTURERS DEFECT THAT CAUSED THE PLASTIC TO BREAK, THEY WILL NOT CREDIT IT..SO HE IS AWARE..(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124020 WHEELCHAIR COMPONENTS 890.3920 KNN UNKNOWN EPAD-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other