BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPRT MATTRESS WITH PENDANT

    MDR report key: 3120399 · Received May 20, 2013

    Report

    Report Number
    0001831750-2013-04547
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FMW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: CUSTOMER TO REPLACE MATTRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT A PATIENT ALLEGEDLY DEVELOPED A PRESSURE ULCER WHILE ON THE XPRT MATTRESS. HOWEVER, THERE WAS NO MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221861 XPRT MATTRESS WITH PENDANT COVER, MATTRESS (MEDICAL PURPOSES) FMW STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1