BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M STEAM CHEMICAL INTEGRATOR

    MDR report key: 12878194 · Received November 24, 2021

    Report

    Report Number
    MW5105597
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    November 23, 2021
    Report Date
    November 23, 2021
    Manufacturer
    3M COMPANY
    Product Code
    JOJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PINK STAINING ON PEEL PACKS FROM 3M STEAM CHEMICAL INTEGRATOR REF.# 1243A, LOT # FG082023. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770072 3M STEAM CHEMICAL INTEGRATOR INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS JOJ 3M COMPANY FG082023

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown