BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPRT MATTRESS W/O PENDANT

    MDR report key: 2883882 · Received November 15, 2012

    Report

    Report Number
    1313850-2012-00338
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLUIDS HAVE LEAKED THROUGH THE MATTRESS COVER AND INTO THE SURFACE. THERE WAS PT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPRT MATTRESS W/O PENDANT MATTRESS FNM STRYKER CORP DBA GAYMAR 2950200000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1