BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3123279 · Received May 21, 2013

    Report

    Report Number
    9616091-2013-00860
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 22, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE WHEEL LOCKS WERE BENT ON A 9SL MANUAL WHEELCHAIR. THIS ISSUE COULD CAUSE THE CHAIR TO ROLL ON AN INCLINE OR CAUSE THE USER TO FALL WHEN ATTEMPTING TO RISE OR SIT INTO THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224030 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9SL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other