BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 19719094 · Received July 11, 2024

    Report

    Report Number
    19719094
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 6, 2024
    Report Date
    June 10, 2024
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OGR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TWO ITEMS WERE REPORTED TO ME YESTERDAY. THESE TWO ITEMS HAD NOTICEABLE DEBRIS AND WAS TAKEN OUT OF THE ROOM BEFORE THE PATIENTS WERE BROUGHT IN. E-MAIL SENT TO SALES REP. MANUFACTURER RESPONSE FOR BOWL IN PROCEDURE PACK, (BRAND NOT PROVIDED) (PER SITE REPORTER). NOTIFIED VIA EMAIL ON [REDACTED DATE].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2347380 CARDINAL HEALTH EAR, NOSE, AND THROAT SURGICAL TRAY OGR CARDINAL HEALTH 200, LLC SEN7CTABRN 23859

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown