BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3200533 · Received July 1, 2013

    Report

    Report Number
    9616091-2013-01124
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 4, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE BOLT FOR THE LEFT WHEEL LOCK ON A SOLARA3G TILT IN SPACE WHEELCHAIR CAME OFF CAUSING THE WHEEL LOCK TO FALL OFF THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300085 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other