BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER

    MDR report key: 1213548 · Received October 27, 2008

    Report

    Report Number
    MW5008786
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 27, 2008
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VERY SMALL, FRAIL FEMALE SLID DOWN IN THE SECURE II BED AND HAD HER CHIN AND LOWER FACE IN THE OPENING OF THE TOP SIDE RAIL NEAREST TO THE CENTER OF THE BED.- ON THE SIDERAILS, THERE ARE TWO OPENINGS FOR HAND GRIPS-ONE ON THE TOP OF THE OTHER.-THE PT HAD SLID DOWN IN THE BED AND GOT HER CHIN AND LOWER FACE IN THE LOWER OF THE TWO OPENINGS. HER LEGS AND HIPS THEN SLID OUT OF THE BED OFF MATTRESS AND SHE WAS HANGING IN THE OPENING OF THE UPPER SIDERAIL. THE BED ALARM WENT OFF AND STAFF RESPONDED IMMEDIATELY. THE PT DID RECEIVE A SKIN TEAR ACROSS HER NECK 4 INCHES HORIZONTALLY AND 1 INCH HIGH WHICH WAS TREATED WITH BACITRACIN AND TELFA. THE PT IS COGNIZANT. DISCLOSURE WAS DONE WITH THE FAMILY. THE PT WAS MOVED TO INPATIENT REHAB AS PLANNED PRIOR TO THE EVENT. THIS COULD HAVE BEEN A VERY SERIOUS EVENT INVOLVING THIS SIDERAIL DESIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER SECURE II MED/SURG BED FNL STRYKER MEDICAL 3002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other