BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACECIDE-C

    MDR report key: 15401651 · Received September 9, 2022

    Report

    Report Number
    MW5111957
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    September 6, 2022
    Report Date
    September 7, 2022
    Manufacturer
    BEST SANITIZERS, INC.
    Product Code
    MED
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    LEAKING CONTAINER OF ACECIDE-C ARRIVED AT THE LOADING DOCK. THE CONTAINER WAS LEAKING INTO THE PLASTIC COVERING. THIS CONTAINER WAS SENT VIA FEDEX. THIS IS OUR 3RD LEAK IN 2.5 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2607824 ACECIDE-C STERILANT, MEDICAL DEVICES MED BEST SANITIZERS, INC. 22188ACE
    2607825 ACECIDE-C STERILANT, MEDICAL DEVICES MED BEST SANITIZERS, INC.
    2607826 ACECIDE-C STERILANT, MEDICAL DEVICES MED BEST SANITIZERS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other