BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACECIDE-C

    MDR report key: 10747370 · Received October 28, 2020

    Report

    Report Number
    10747370
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    October 2, 2020
    Report Date
    October 2, 2020
    Manufacturer
    BEST SANITIZERS INC.
    Product Code
    MED
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    UPON OPENING BOX OF ACECIDE CHEMICAL, THE (B)(4) BAG CONTAINING THE BOTTLES OF CHEMICALS IS WET AND THE BOTTLES ARE LEAKING. THERE IS A STRONG CHEMICAL SMELL. UNABLE TO DETERMINE LOCATION OF LEAK/BREAK/CRACK IN EITHER BOTTLE OF ACECIDE-C SOLUTION 1 & 2. IN THE PAST 3 WEEKS THERE HAVE BEEN 14 BOXES WITH LEAKING CONTAINERS (NOT COUNTING THIS EVENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212246 ACECIDE-C STERILANT, MEDICAL DEVICES MED BEST SANITIZERS INC. 20231ACE

    Patients

    Seq Age Sex Outcome Treatment
    1