BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3092882 · Received May 3, 2013

    Report

    Report Number
    9616091-2013-00745
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 9, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED BACK UPHOLSTERY HAS STARTED TO RIP BY THE TOP SCREWS ON THE RIGHT. BECAUSE OF HIS CONDITION, HE PUTS ALL HIS WEIGHT ON THE RIGHT SIDE WHEN HE SELF PROPELS THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194522 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T422RDA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other