BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STD C-SECTION PACK

    MDR report key: 18266945 · Received December 4, 2023

    Report

    Report Number
    MW5148759
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    December 1, 2023
    Report Date
    December 1, 2023
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OHM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SETTING UP FOR CASE IN OR (OPERATING ROOM), SURG TECH OPENED STERILE PACK AND FOUND PIECES OF CARDBOARD IN THE PACK, TECH HAD TO THEN STOP, UNSCRUB, GET NEW PACK, RE SCRUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2177802 STD C-SECTION PACK CESAREAN SECTION TRAY OHM CARDINAL HEALTH 200, LLC SMA4ECSHTB 141711

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown