BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 13250362 · Received January 13, 2022

    Report

    Report Number
    13250362
    Event Type
    Malfunction
    Date Received
    January 13, 2022
    Date of Event
    January 10, 2022
    Report Date
    January 12, 2022
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    NWU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NARRATIVE FROM STAFF: IT HAS BEEN REPORTED THAT WE ARE SEEING AN INCREASE IN MAYO STAND COVERS HAVING HOLES IN THEM. STAFF HAVE SAVED TWO OF THE THREE PACK LIST FROM THE PACKS THAT THESE MAYO STAND COVERS HAVE COME OUT OF. THE MAYO STAND COVERS ARE COMING OUT OF THE GENERAL ENDO OSC PACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1404613 CARDINAL HEALTH ENDOSCOPE INTRODUCER KIT NWU CARDINAL HEALTH 200, LLC SBA13LCEM4 725131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown