BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M STERI-GAS EO GAS CARTRIDGE

    MDR report key: 2316680 · Received October 27, 2011

    Report

    Report Number
    2110898-2011-00107
    Event Type
    Injury
    Date Received
    October 27, 2011
    Date of Event
    September 26, 2011
    Report Date
    September 26, 2011
    Manufacturer
    3M HEALTH CARE
    Product Code
    FLI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER ADVERSE PT EFFECTS WERE REPORTED. IF ADDITIONAL INFO IS RECEIVED, A F/U REPORT WILL BE SUBMITTED. DEFINITION OF EVAL: CONCLUSION - NO EVAL WILL BE PERFORMED.

    Description of Event or Problem · 1

    3M RECEIVED INFO FROM A CUSTOMER WITH APL (ACUTE PROMYELOCYTIC LEUKEMIA), AN EMPLOYEE FOR A FACILITY WHERE HE HAD PAST OCCUPATIONAL EXPOSURE TO HIGH LEVELS OF ETHYLENE OXIDE (EO), ATTRIBUTES HIS DISEASE TO GENERAL FACILITY EXPOSURE TO EO AND LACK OF FOLLOW-UP/INADEQUATE RECORDS OF SAMPLING AT THE FACILITY. THE EMPLOYEE EXPLAINED TO 3M OCCUPATIONAL HEALTH THAT HE DOES NOT BELIEVE THE 3M STERI-GAS EQUIPMENT IS A PROBLEM AND UNDERSTANDS THE 3M DEVICE MEETS ALL CARTRIDGES ARE A PROBLEM. HE FILED WORKER'S COMPENSATION (WC) CLAIM IN THE FEDERAL SYSTEM AND HAS BEEN DENIED AT PRESENT (FED. WC AGREED HE WAS ABLE TO SHOW THAT HE HAD BEEN EXPOSED TO EO ABOVE THE LEGAL LIMITS AND AGREED HE WAS ABLE TO SHOW THAT HE WAS DIAGNOSED WITH APL, BUT DID NOT SHOW CONNECTION/LINK BETWEEN EO EXPOSURE AND APL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M STERI-GAS EO GAS CARTRIDGE 880.6860 STERILIZER, ETHYLENE-OXIDE GAS FLI 3M HEALTH CARE NA NK

    Patients

    Seq Age Sex Outcome Treatment
    1 NK Life Threatening