BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 11699862 · Received April 21, 2021

    Report

    Report Number
    11699862
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    April 2, 2021
    Report Date
    April 2, 2021
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OHM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FROM STAFF: DURING A C-SECTION THE CERTIFIED SURGICAL TECHNICIAN PICKED UP A LAP SPONGE OFF THE TABLE AND THE BLUE TAG ON THE END CAME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600442 CARDINAL HEALTH CESAREAN SECTION TRAY OHM CARDINAL HEALTH 200, LLC SMA13CCEM4 560257

    Patients

    Seq Age Sex Outcome Treatment
    1