BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 11574398 · Received March 26, 2021

    Report

    Report Number
    11574398
    Event Type
    Malfunction
    Date Received
    March 26, 2021
    Date of Event
    March 1, 2021
    Report Date
    March 18, 2021
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OHM
    UDI-DI
    10193489498899
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHEN OPENING A C/S PACKAGE FROM MEDLINE AND THE BLUE OUTER WRAP LAYER HAD A HOLE. IT WAS DISCARDED AND OPENED ANOTHER ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472958 MEDLINE INDUSTRIES, INC. CESAREAN SECTION TRAY OHM MEDLINE INDUSTRIES, INC. DYNJ68111 10193489498899

    Patients

    Seq Age Sex Outcome Treatment
    1