BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3970378 · Received July 31, 2014

    Report

    Report Number
    9616091-2014-01385
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER ADVISED RIGHT FRONT RIGGING RELEASES OUT INTERMITTENTLY. DEALER COULD NOT DUPLICATE ISSUE. NO INJURY. DEALER COULD NOT PROVIDE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447790 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX GVTRSX58

    Patients

    Seq Age Sex Outcome Treatment
    1 Other