BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4201874 · Received October 27, 2014

    Report

    Report Number
    9616091-2014-02256
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Report Date
    October 23, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE RIGHT ARMPAD AND BOTH CLOTHING GUARDS ARE CRACKED ON THE TREX28RF WHEELCHAIR. THE SIDE GUARDS COULD BE CRACKING BECAUSE USER PUTS EXTREME WEIGHT ON THE ARMS WHEN TRANSFERRING. USER REPORTED THAT THE CLOTHING GUARDS WERE PINCHING HER AND RUBBING AGAINST HER SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681307 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TREX28RF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other