BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3200477 · Received July 1, 2013

    Report

    Report Number
    9616091-2013-01116
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 6, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE PROVIDER REPORTED THE REAR WHEEL IS DETACHING FROM THE RIM ON THE TRSX52FB POWERED WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298222 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX52FB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other