BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAYMAR INDUSTRIES, INC.

    MDR report key: 1335397 · Received March 5, 2009

    Report

    Report Number
    MW5010187
    Event Type
    Malfunction
    Date Received
    March 5, 2009
    Date of Event
    February 3, 2009
    Report Date
    February 9, 2009
    Manufacturer
    GAYMAR INDUSTRIES
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MATTRESS HAS FAILED TO PROVIDE PRESSURE RELIEF FOR ICU PATIENTS. MATTRESSES PURCHASED IN 2005. A TOTAL PATIENTS HAVE DEVELOPED PRESSURE SORES IN ICU SINCE 2005. THE GEL MATERIAL INSIDE MATTRESS COVER HAS LOST ABILITY TO RECOVER AND DOES NOT PROVIDE PRESSURE RELIEF. DATES OF USE: 2005 - PRESENT. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAYMAR INDUSTRIES, INC. STRYKER ISOFLEX IKY GAYMAR INDUSTRIES 2800
    10 GAYMAR INDUSTRIES, INC. STRYKER ISOFLEX IKY GAYMAR INDUSTRIES
    11 GAYMAR INDUSTRIES, INC. STRYKER ISOFLEX IKY GAYMAR INDUSTRIES
    2 GAYMAR INDUSTRIES, INC. STRYKER ISOFLEX IKY GAYMAR INDUSTRIES
    3 GAYMAR INDUSTRIES, INC. STRYKER ISOFLEX IKY GAYMAR INDUSTRIES
    4 GAYMAR INDUSTRIES, INC. STRYKER ISOFLEX IKY GAYMAR INDUSTRIES
    5 GAYMAR INDUSTRIES, INC. STRYKER ISOFLEX IKY GAYMAR INDUSTRIES
    6 GAYMAR INDUSTRIES, INC. STRYKER ISOFLEX IKY GAYMAR INDUSTRIES
    7 GAYMAR INDUSTRIES, INC. STRYKER ISOFLEX IKY GAYMAR INDUSTRIES
    8 GAYMAR INDUSTRIES, INC. STRYKER ISOFLEX IKY GAYMAR INDUSTRIES
    9 GAYMAR INDUSTRIES, INC. STRYKER ISOFLEX IKY GAYMAR INDUSTRIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other