BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOGEL 2860 AFTERMARKET

    MDR report key: 3761099 · Received April 21, 2014

    Report

    Report Number
    0001831750-2014-02921
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL AND FUNCTIONAL INSPECTION WAS ALLEGEDLY PERFORMED BY HOSPITAL STAFF AND MANUFACTURER'S SALES REP. THERE WAS NO MALFUNCTION ALLEGED AND NO APPARENT MALFUNCTION FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER IS ALLEGING AN INCREASE IN PRESSURE ULCERS WITHIN THE LAST 6 MONTHS OF PUTTING ISOGEL MATTRESS INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER IS ALLEGEDING AN INCREASE IN PRESSURE ULCERS WITHIN THE LAST 6 MONTHS OF PUTTING ISOGEL MATTRESS INTO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240454 ISOGEL 2860 AFTERMARKET MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1