BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPRT SLEEP SURFACE

    MDR report key: 2190675 · Received July 29, 2011

    Report

    Report Number
    1313850-2011-00180
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    STRYKER CORP. DBA GAYMAR
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MATTRESS HAD EVIDENCE OF FLUID INTRUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPRT SLEEP SURFACE MATTRESS FNM STRYKER CORP. DBA GAYMAR 2950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1