BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERI-GAS, STERI-VAC

    MDR report key: 374102 · Received January 18, 2002

    Report

    Report Number
    2110898-2002-00003
    Event Type
    Malfunction
    Date Received
    January 18, 2002
    Date of Event
    June 14, 2001
    Report Date
    January 17, 2002
    Manufacturer
    3M
    Product Code
    FLI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL MAINTAINANCE WORKER EXPOSED TO ETHYLENE OXIDE GAS. MEDICAL ATTENTION SOUGHT FOR COMPLAINT OF IRRITATION TO SKIN, EYES, AND RESPIRATORY SYSTEM. TREATED BY A PHYSICIAN FOR MILD IRRITATION AND IS CURRENTLY ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERI-GAS, STERI-VAC GAS CARTRIDGE FLI 3M * *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other