BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2923458 · Received January 22, 2013

    Report

    Report Number
    1525712-2013-00474
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    January 17, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES THOUGHT THE ARM PAD TO HAVE BEEN LOOSE, ONLY NEEDED TIGHTENED BACK ON. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29481 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M91R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other