BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3121182 · Received May 20, 2013

    Report

    Report Number
    9616091-2013-00848
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 24, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER ADVISED THAT THE WHEEL HAS SNAPPED HAS SHARP EDGES AND IS NOT SMOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222830 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9XT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other