BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM204 M-SERIES W/BIG WHEEL

    MDR report key: 1853053 · Received September 21, 2010

    Report

    Report Number
    1831750-2010-02459
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    STRYKER CORP, MEDICAL DIV.
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIDERAIL SPACER BROKE ON SIDERAIL CAUSING SIDERAIL NOT TO LATCH PROPERLY. THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM204 M-SERIES W/BIG WHEEL HOSPITAL WHEELED STRECHER FPO STRYKER CORP, MEDICAL DIV. 1015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA