BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M

    MDR report key: 513003 · Received February 18, 2004

    Report

    Report Number
    MW1031240
    Event Type
    Malfunction
    Date Received
    February 18, 2004
    Date of Event
    February 11, 2004
    Report Date
    February 12, 2004
    Manufacturer
    *
    Product Code
    JOJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INTEGRATER STRIP DID NOT INDICATE THAT PARAMETERS OF STERILIZATION WERE MET. THE REMAINING STRIPS IN THE SAME LOAD CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M STEAM CHEMICAL INTEGRATOR JOJ * * 200811BA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other