BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACECIDE-C

    MDR report key: 11472802 · Received March 11, 2021

    Report

    Report Number
    MW5099967
    Event Type
    Malfunction
    Date Received
    March 11, 2021
    Date of Event
    March 9, 2021
    Report Date
    March 10, 2021
    Manufacturer
    BEST SANITIZERS, INC.
    Product Code
    MED
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRODUCT FOUND LEAKING (DROPLETS INSIDE INNER BAG) ON REMOVAL FROM INTERNAL BOX..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355571 ACECIDE-C STERILANT, MEDICAL DEVICES MED BEST SANITIZERS, INC. 2025ACE

    Patients

    Seq Age Sex Outcome Treatment
    1