BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4090473 · Received September 15, 2014

    Report

    Report Number
    1525712-2014-05868
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 28, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE RUBBER ON THE FOOTBOARD FOR A M51PR POWER CHAIR HAS COME OFF, USER HAS CUT HER LEG. UNKNOWN IF MEDICAL ATTENTION WAS SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570288 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M51PR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other