BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3771660 · Received April 24, 2014

    Report

    Report Number
    9616091-2014-00755
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    February 24, 2014
    Report Date
    March 24, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE RIGHT REAR ARM SOCKET CUP FOR A SOLOAR3G TILT IN SPACE WHEELCHAIR HAS SNAPPED OFF COMPLETELY BY UNKNOWN CIRCUMSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249583 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other