BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2981446 · Received February 27, 2013

    Report

    Report Number
    9616091-2013-00298
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER STATED THAT THE CHAIR HAS A BROKEN FRAME AT WELD ON BOTTOM IN THE BACK OF THE CHAIR WHICH COULD CAUSE THE CHAIR TO BE UNSTABLE AND POSSIBLY COLLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84780 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other