BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2993496 · Received March 7, 2013

    Report

    Report Number
    1525712-2013-01751
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 11, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE DEALER REPORTED THAT THE PROX4S CUSTOM MECHANICAL WHEELCHAIR WAS VEERING TO THE LEFT WHEN GOING FORWARD. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97043 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET PROX4S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other