BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4232675 · Received November 6, 2014

    Report

    Report Number
    1525712-2014-07677
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 20, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASTER ON THE (B)(4) POWER CHAIR WAS REPLACED AND DID NOT ORDER NEW MOUNTING HARDWARE BUT INSTEAD USED THE OLD HARDWARE TO ATTACH IT. PROVIDER ADVISED THAT THE HARDWARE BROKE WHILE CUSTOMER WAS USING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713651 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M91R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other