BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 20782352 · Received November 26, 2024

    Report

    Report Number
    20782352
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    August 16, 2024
    Report Date
    October 16, 2024
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OJH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    STERILE KNEE ARTHROSCOPY PACK CONSISTED OF 4 LAP SPONGES INSTEAD OF 5. CATALOG SOPOCNKSRC, LOT 311219. MANUFACTURER RESPONSE FOR KNEE ARTHROSCOPY PACK, KNEE ARTHROSCOPY PACK (PER SITE REPORTER). NOTIFIED REP, [REDACTED NAME].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2434489 CARDINAL HEALTH ORTHOPEDIC TRAY OJH CARDINAL HEALTH 200, LLC SOPOCNKSRC 311219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose