BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2800-000-000-35X84 P NYLA

    MDR report key: 2922153 · Received January 11, 2013

    Report

    Report Number
    1313850-2013-90002
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED TO THE MFR FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER ALLEGED AN INCREASE IN PRESSURE ULCER DEVELOPMENT AT THEIR FACILITY. THE USER FACILITY DID NOT PROVIDE ANY SPECIFIC DETAILS OR A SERIAL NUMBER OF THE DEVICE FOR THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18529 2800-000-000-35X84 P NYLA MATTRESS FNM STRYKER CORP DBA GAYMAR IMR000000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1