BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHYLENE-OXIDE STERILYZER

    MDR report key: 34638 · Received July 25, 1996

    Report

    Report Number
    MW1009570
    Event Type
    Malfunction
    Date Received
    July 25, 1996
    Manufacturer
    MDT BIOLOGIC CO.
    Product Code
    FLF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LEAK IN GASKET OF HEAT EXCHANGERS OF ETO STERILIZER. NEEDED TO BE REPLACED SEVERAL TIMES - POSSIBLE EMPLOYEE EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHYLENE-OXIDE STERILYZER ETHYLENE-OXIDE STERILYZER FLF MDT BIOLOGIC CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA