BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYMMETRIC AIRE; PENN-NYLA

    MDR report key: 2357603 · Received November 22, 2011

    Report

    Report Number
    1313850-2011-00454
    Event Type
    Other
    Date Received
    November 22, 2011
    Date of Event
    October 28, 2011
    Report Date
    October 28, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL COMPLAINT OF SAGGING IS NOT LIKELY TO CONTRIBUTE TO OR CAUSE SERIOUS INJURY OR DEATH, AS THE PT WOULD STILL BE SUPPORTED BY THE BOTTOM LAYER FOAM AND THE FOAM INSIDE THE AIR CELLS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MATTRESS WAS SAGGING. UPON EVALUATION, WHEN THE COVER WAS OPENED STAINING WAS PRESENT, WHICH SUGGESTS FLUID INGRESS OCCURRED. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMMETRIC AIRE; PENN-NYLA MATTRESS FNM STRYKER CORP DBA GAYMAR 2750100000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1