BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX 35X84X6 NYLON

    MDR report key: 5114069 · Received September 30, 2015

    Report

    Report Number
    0001831750-2015-00460
    Event Type
    Injury
    Date Received
    September 30, 2015
    Date of Event
    July 28, 2015
    Report Date
    July 28, 2015
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IKY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A GENERAL INCREASE IN HAPU (HOSPITAL-ACQUIRED PRESSURE ULCER) OCCURRENCES ON THE ISOFLEX MATTRESSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645695 ISOFLEX 35X84X6 NYLON MATTRESS, FLOTATION THERAPY, NON-POWERED IKY STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1