BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 7098968 · Received December 8, 2017

    Report

    Report Number
    7098968
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    December 3, 2017
    Report Date
    December 5, 2017
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OJF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SCRUB TECH OPENED PACK FOR UROLOGY CASE, THEY FOUND HAIR INSIDE STERILE PACK. WE BROKE DOWN BACK TABLE AND WASTED ALL ITEMS INCLUDED IN PACK AND OPENED NEW PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878702 CARDINAL HEALTH HYSTERECTOMY KIT OJF CARDINAL HEALTH 200, LLC SMA56LP20A 722215

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR