BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2970005 · Received February 20, 2013

    Report

    Report Number
    1525712-2013-01274
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Report Date
    February 19, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    DEALER STATES SOME SCREWS FELL OUF OF THE QUAD LINK - IVC REP INFORMED DEALER THIS DOES NOT SOUND LIKE A MANUFACTURING DEFECT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73522 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M51PR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other