BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAYMAR SYMMETRIC AIRE MATTRESS

    MDR report key: 1210926 · Received October 23, 2008

    Report

    Report Number
    MW5008742
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Report Date
    October 23, 2008
    Manufacturer
    GAYMAR INDUSTRIES INC.
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE PURCHASED 48 SYMMETRIC AIRE MATTRESSES IN FEBRUARY OF 2008 - WE EXPERIENCED OVER INFLATION OF AIR CELLS IN 4 OUT OF THE 7 MATTRESSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAYMAR SYMMETRIC AIRE MATTRESS SYM AIRE MATTRESS FNM GAYMAR INDUSTRIES INC. SYM3584

    Patients

    Seq Age Sex Outcome Treatment
    1