BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPRT SLEEP SURFACE

    MDR report key: 2190443 · Received July 29, 2011

    Report

    Report Number
    1313850-2011-00182
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    INX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SERIAL NUMBER, THEREFORE NO PRODUCT EVALUATION COULD BE MADE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE MATTRESS OF THE BED HAS VERY LITTLE AIR UNDER THE PATIENT WHEN USING THE MATTRESS IN ROTATION MODE. IT WAS FURTHER REPORTED THAT THIS CAUSES DISCOMFORT AND COULD ALSO ALLEGEDLY BE A CONTRIBUTING FACTOR TO REPORTS OF PRESSURE ULCERS ON PATIENTS USING THE BEDS WITH THE MATTRESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1