BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH HAND PODIATRY PACK

    MDR report key: 22622795 · Received July 28, 2025

    Report

    Report Number
    22622795
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    July 8, 2025
    Report Date
    July 8, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OJH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMMEDIATELY OPENED HAND PODIATRY PACK AND SAW A HOLE OR PACKAGE INTEGRITY ISSUE. IT APPEARED TO BE A HOLE, BUT ALSO SOMETHING BLACK MELTED INTO THE PACK ITSELF. OUTSIDE PACKAGE WAS FINE. HAND PODIATRY PACK, SOP40HPBHC, MANU: 2024-10-14, MANU: CARDINAL HEALTH, LOT# 377061, EXP. 2027-05-01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100049 CARDINAL HEALTH HAND PODIATRY PACK ORTHOPEDIC TRAY OJH CARDINAL HEALTH 200, LLC SOP40HPBHC 377061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown