BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERI-GAS 4-100 CARTRIDGE

    MDR report key: 297906 · Received September 19, 2000

    Report

    Report Number
    2110898-2000-00013
    Event Type
    Malfunction
    Date Received
    September 19, 2000
    Report Date
    September 15, 2000
    Manufacturer
    3M
    Product Code
    FLI
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SEVERAL EMPLOYEES OF HOSP HAVE PRESENTED ELEVATED LIVER ENZYMES WHICH THEY ATRRIBUTE TO EXPOSURE TO ETHYLENE OXIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERI-GAS 4-100 CARTRIDGE EO GAS CARTRIDGE FLI 3M NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other