BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAYMAR INDUSTRIES, INC.

    MDR report key: 1496602 · Received October 7, 2009

    Report

    Report Number
    MW5012913
    Event Type
    Malfunction
    Date Received
    October 7, 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

    PT WAS ASSESSED AS NO RISK FOR SKIN BREAKDOWN. PT WAS ON ISFLEX GAYMAR MATTRESS, PURCHASED IN 2009. PT WAS NOTED WITH NEW DEEP TISSUE INJURY. STRYKER COMPANY WAS CONTACTED. ALL MATTRESSES WERE INSPECTED AND 4 OF 12 MATTRESSES INSPECTED HAD QUESTIONABLE AREAS. EIGHT MONTHS AFTER PURCHASED, THE DEEP TISSUE INJURY IS NOTED AS STAGE 2 SM 1CM EACH, BOTTOM RED. SKIN BREAKDOWN. PATIENT WITH NO RISK. SUSPECT FOUR MATTRESSES ARE DEFECTIVE. DATES OF USE: 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAYMAR INDUSTRIES, INC. STRYKER ISOFLEX IKY GAYMAR INDUSTRIES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR