BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 1243782 · Received November 24, 2008

    Report

    Report Number
    1525712-2008-00126
    Event Type
    Injury
    Date Received
    November 24, 2008
    Report Date
    November 21, 2008
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER RECEIVED INFORMATION THAT A WHEEL RIM HAD BROKE RESULTING IN CONSUMER FALLING OUT OF CHAIR AND BREAKING THEIR SHOULDER. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME, SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MDR FILED ON ALLEGED SERIOUS INJURY.

    Description of Event or Problem · 1

    THE RIGHT SIDE CASTER RIM ALLEGEDLY BROKE, CAUSING THE CONSUMER TO FALL AND BREAK HIS SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE 3GTQ3-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention