BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3062278 · Received April 16, 2013

    Report

    Report Number
    9616091-2013-00640
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 20, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH A T4X22RDA MANUAL WHEELCHAIR WITH A FRAME THAT IS BROKEN AT A WELD. THIS EVENT CAN CAUSE THE CHAIR TO BECOME UNSTABLE AND POSSIBLY COLLAPSE, INJURING THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162936 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T4X24RDA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other