BEUDAMED
    FDA Adverse Event Summary report: N

    ACECIDE-C SOLUTION

    MDR report key: 11278866 · Received February 3, 2021

    Report

    Report Number
    MW5099219
    Date Received
    February 3, 2021
    Date of Event
    November 12, 2020
    Report Date
    February 2, 2021
    Manufacturer
    OLYMPUS / BEST SANITIZERS, INC.
    Product Code
    MED
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ACECIDE-C LEAKING INSIDE THE PLASTIC PACKAGING. LEAKS HAVE BEEN DETECTED ON THREE SEPARATE INSTANCES - (B)(6) 2020 (LOT# 20245ACE1&2), (B)(6) 2021 (20339ACE1&2), (B)(6) 2021 (20345ACE1&2). EACH TIME, MULTIPLE CONTAINERS HAVE LEAKED INSIDE PLASTIC PACKAGING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173257 ACECIDE-C SOLUTION STERILANT, MEDICAL DEVICES MED OLYMPUS / BEST SANITIZERS, INC. 20245ACE1
    173258 ACECIDE-C SOLUTION STERILANT, MEDICAL DEVICES MED OLYMPUS / BEST SANITIZERS, INC. 20245ACE2
    173259 ACECIDE-C SOLUTION STERILANT, MEDICAL DEVICES MED OLYMPUS / BEST SANITIZERS, INC. 20339ACE1
    173260 ACECIDE-C SOLUTION STERILANT, MEDICAL DEVICES MED OLYMPUS / BEST SANITIZERS, INC. 20339ACE2
    173261 ACECIDE-C SOLUTION STERILANT, MEDICAL DEVICES MED OLYMPUS / BEST SANITIZERS, INC. 20345ACE1
    173262 ACECIDE-C SOLUTION STERILANT, MEDICAL DEVICES MED OLYMPUS / BEST SANITIZERS, INC. 20345ACE2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other