BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 22394055 · Received July 3, 2025

    Report

    Report Number
    22394055
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    May 28, 2025
    Report Date
    June 27, 2025
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OHD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    WHILE SETTING UP THE BACK TABLE FOR OUR CASE, ST [SURGICAL TECHNICIAN] NOTICED A DEAD BUG IN THE TRASH BAG PROVIDED IN THE STERILE PACK. UNFORTUNATELY, THIS WAS AT THE END OF SET UP AND WE HAD TO BREAK DOWN THE TABLE, ALL SUPPLIES AND INSTRUMENTS. MANUFACTURER RESPONSE FOR GYNECOLOGICAL LAPAROSCOPIC KIT, MEDLINE INDUSTRIES, INC. (PER SITE REPORTER). WAITING FOR THEIR RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176940 MEDLINE INDUSTRIES, INC. GYNECOLOGICAL LAPAROSCOPIC KIT OHD MEDLINE INDUSTRIES, INC. DYNJ52821G 25DMD752

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown