BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2800-000-000 35X84 P NYLA

    MDR report key: 3459538 · Received November 8, 2013

    Report

    Report Number
    0001831750-2013-10680
    Event Type
    Injury
    Date Received
    November 8, 2013
    Date of Event
    October 11, 2013
    Report Date
    October 11, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IKY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSION: THE FACILITY ADDITIONALLY ALLEGED THERE WAS A REDUCTION IN PATIENT SUPPORT. PRESSURE REDISTRIBUTION IS PROVIDED BY GEL AS WELL AS THE SECONDARY FOAM SUPPORT STRUCTURE. PER THE CUSTOMER'S PREFERENCE AND REQUEST, THE MATTRESS WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY REPAIR WORK ORDER THAT THE PATIENT'S SKIN BROKE DOWN ON THE MATTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578541 2800-000-000 35X84 P NYLA BED, AC-POWERED ADJUSTABLE HOSPITAL IKY STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1