BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M 8XL ETO STERILIZER

    MDR report key: 797277 · Received December 21, 2006

    Report

    Report Number
    MW1041404
    Event Type
    Injury
    Date Received
    December 21, 2006
    Date of Event
    December 4, 2006
    Report Date
    December 20, 2006
    Manufacturer
    3M
    Product Code
    MLR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RECEIVED A POSITIVE BIOLOGICAL FROM 8XL ETO STERILIZER WHICH WAS RUN 12/02/2006. ALL MECHANICAL INDICATORS FOR TIME, TEMPERATURE, HUMIDITY WERE READING APPROPRIATE. THERE WERE NO ERROR OR CAUTION MESSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M 8XL ETO STERILIZER ETO STERILIZER MLR 3M 8XL *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Disability