BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE BRUSHES

    MDR report key: 18884909 · Received March 8, 2024

    Report

    Report Number
    MW5152598
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    March 5, 2024
    Report Date
    March 5, 2024
    Manufacturer
    HEALTHMARK INDUSTRIES CO., INC.
    Product Code
    MNL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    STERILE PROCESSING PRODUCT PACKAGE EXPIRATION AND LOT NUMBER DISCREPANCY FOR PRODUCTS INSIDE PACKAGE VERSUS EXPIRATION AND LOT NUMBER ON OUTSIDE PACKAGE. CONCERN IF PRODUCTS INSIDE WERE TO BE RECALLED, FACILITY WOULD HAVE NO WAY OF KNOWING THE ACTUAL LOT NUMBER OF PRODUCTS INSIDE PACKAGE. BOX: EXPIRATION 3/15/2024 AND LOT #26049 BOTTLE PRODUCT: EXPIRATION 2/9/2025, AND LOT#97133. UNIVERSAL CHANNEL CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957097 ENDOSCOPE BRUSHES ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE MNL HEALTHMARK INDUSTRIES CO., INC. 26049/97133

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other