BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4111307 · Received September 23, 2014

    Report

    Report Number
    9616091-2014-01956
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 3, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DEALER THAT THE TRSX5RC WHEELCHAIR WAS MISSING THE CONNECTOR BAR THAT CONNECTS THE SPREADER BAR ON THE RECLINING BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590282 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX5RC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other