BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM LAPRASCOPIC PACK

    MDR report key: 20587073 · Received October 31, 2024

    Report

    Report Number
    MW5162019
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 21, 2024
    Report Date
    October 28, 2024
    Manufacturer
    AMERICAN CONTRACT SYSTEMS
    Product Code
    OHD
    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

    WHEN THE STAFF OPENED UP THE DOUBLE BASIN THAT WAS INSIDE OF THE OWENS AND MINOR CUSTOM LAPAROSCOPIC PACK THE WRAPPER INSIDE OF THE PACK HAD 2 HOLES. THIS MEANT THAT THE DOUBLE BASIN COULD NOT BE USED AS IT WAS NOT STERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91493 CUSTOM LAPRASCOPIC PACK GYNECOLOGICAL LAPAROSCOPIC KIT OHD AMERICAN CONTRACT SYSTEMS 1610636

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other