BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 1481573 · Received September 17, 2009

    Report

    Report Number
    MW5012796
    Event Type
    Injury
    Date Received
    September 17, 2009
    Date of Event
    December 14, 2008
    Report Date
    September 17, 2009
    Manufacturer
    UNKNOWN
    Product Code
    IOE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN A WHEELCHAIR, AND WHEELED HERSELF UP TO A SET OF PARALLEL BARS WITH A THRESHOLD. WHEN THE WHEELCHAIR ROLLED OVER THE THRESHOLD, THE WHEELCHAIR TIPPED BACK RESULTING IN A HEAD INJURY. THE EVENT OCCURRED IN 2008. A LETTER DATED 8/09 WAS RECEIVED ALLEGING EQUIPMENT CONTRIBUTED TO THE INJURY. INVESTIGATION PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PARALLEL BARS IOE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization