BEUDAMED
    FDA Adverse Event Other Summary report: N

    SM204 M-SERIES W/BIG WHEEL

    MDR report key: 1509871 · Received October 14, 2009

    Report

    Report Number
    1831750-2009-01398
    Event Type
    Other
    Date Received
    October 14, 2009
    Date of Event
    September 16, 2009
    Report Date
    September 16, 2009
    Manufacturer
    STRYKER CORP, MEDICAL DIVISION
    Product Code
    FPO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION BY THE SERVICE TECHNICIAN, A SHARP EDGE WAS CREATED FROM THE SIDERAILS BEING LOWERED WITH FORCE OR FROM IMPACT DAMAGE FROM THE SIDERAILS BEING DOWN AND RUN INTO WALLS OR DOORWAYS.

    Description of Event or Problem · 1

    IT WAS REPORTED, THERE WAS A SHARP EDGE ON THE PLASTIC SECTION OF THE SIDERAIL. IT WAS REPORTED, A PERSON CUT THEIR ARM ON THE SIDERAIL, HOWEVER, NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK