BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2984602 · Received February 28, 2013

    Report

    Report Number
    1525712-2013-01542
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    January 31, 2013
    Manufacturer
    UNKNOWN
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. LEGAL REPRESENTATIVE STATES CONSUMERS DAUGHTER WAS PUSHING HER MOTHER IN A HIGH BACK WHEELCHAIR WHILE ATTEMPTING TO GO OVER A DOOR JAM. THE HANDLE BAR ALLEGEDLY CAME OFF THE CHAIR, CAUSING HER TO FALL BACKWARD AND FRACTURE HER WRIST. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87643 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other