BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3346319 · Received September 12, 2013

    Report

    Report Number
    1525712-2013-07787
    Event Type
    Malfunction
    Date Received
    September 12, 2013
    Report Date
    September 4, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    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

    IT WAS REPORTED THAT THE PIVOT LINK OF A PROX4S MANUAL WHEELCHAIR WAS CRACKED WHEN THE CHAIR WAS FOLDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459802 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET PROX4S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other