BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEDGE TURNING FRAME

    MDR report key: 2243271 · Received September 1, 2011

    Report

    Report Number
    1831750-2011-09392
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A F/U REPORT WILL BE SUBMITTED SHOULD ANY ADD'L INFO BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE STRETCHER BROKE AND THE PT ALMOST FELL OFF. STAFF MEMBERS WERE PRESENT AND CAUGHT THE PT, PREVENTING THE FALL. NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WEDGE TURNING FRAME HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 0965 NA

    Patients

    Seq Age Sex Outcome Treatment
    1