BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX 35X84 DARTEX W/FB

    MDR report key: 2960149 · Received February 13, 2013

    Report

    Report Number
    0001831750-2013-01131
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IKY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MATTRESS NOT BEING RETURNED TO MANUFACTURER FOR EVALUATION; NO PRODUCT MALFUNCTION IS ALLEGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S SKIN BROKE DOWN WHILE ON THE MATTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62385 ISOFLEX 35X84 DARTEX W/FB MATTRESS, FLOTATION THERAPY, NON-POWERED IKY STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1