BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACECIDE-C

    MDR report key: 15371324 · Received September 6, 2022

    Report

    Report Number
    MW5111893
    Event Type
    Malfunction
    Date Received
    September 6, 2022
    Date of Event
    August 23, 2022
    Report Date
    September 2, 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 CASE OF ACECIDE-C RECEIVED FROM (B)(6). LEAKAGE HAD BEEN DETECTED BY (B)(6) AND WAS REPACKAGED BY THEM AND SHIPMENT CONTINUED TO DESTINATION. LEAKAGE WAS NOT DETECTED BY RECEIVING FACILITY UNTIL OUTER REPACKAGING WAS OPENED. OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665655 ACECIDE-C STERILANT, MEDICAL DEVICES MED BEST SANITIZERS, INC. 22174ACE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other