BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACECIDE C HIGH LEVEL DISINFECTANT AND STERILANT

    MDR report key: 12614635 · Received October 12, 2021

    Report

    Report Number
    12614635
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    October 5, 2021
    Report Date
    October 5, 2021
    Manufacturer
    BEST SANITIZERS, INC.
    Product Code
    MED
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STRONG CHEMICAL ODOR IN SUPPLY ROOM. PRODUCT FOUND IN ORIGINAL SEALED PACKAGING. CHEMICAL FOUND LEAKING IN SEALED PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513731 ACECIDE C HIGH LEVEL DISINFECTANT AND STERILANT STERILANT, MEDICAL DEVICES MED BEST SANITIZERS, INC. 220731 21189ACE

    Patients

    Seq Age Sex Outcome Treatment
    1