BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEATHERLIGHT TRANSPORT CHAIR

    MDR report key: 5851646 · Received August 5, 2016

    Report

    Report Number
    1056127-2016-00010
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Date of Event
    July 18, 2016
    Report Date
    July 18, 2016
    Manufacturer
    SHANGHAI HUBANG MEDICAL APPLIANCES CO LTD
    Product Code
    INN
    UDI-DI
    00754756140038
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PATIENT BOUGHT THIS TRANSPORT CHAIR AT A GARAGE SALE AND BROUGHT IT TO A (B)(4) FOR SERVICING AND WANTED A REPLACEMENT FRONT FORK ASSEMBLY. UPON INSPECTION, THE SERVICE TECH DETERMINED THAT THE CASTER STUD WAS BENT AND THE THREADS WERE DAMAGED AND HE COULD NOT SAFELY REPAIR THE CHAIR. THERE WAS NO CRITICAL EVENT OR INJURY, ABSENT INFORMATION, EVENT DATE IS DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502988 FEATHERLIGHT TRANSPORT CHAIR TRANSPORT CHAIR, INVALID CHAIR INN SHANGHAI HUBANG MEDICAL APPLIANCES CO LTD DC150111 N/A 00754756140038

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR