BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESOURCE

    MDR report key: 8300885 · Received February 4, 2019

    Report

    Report Number
    8300885
    Event Type
    Malfunction
    Date Received
    February 4, 2019
    Date of Event
    January 23, 2019
    Report Date
    January 23, 2019
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OJF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS BROUGHT TO MY ATTENTION TODAY, THAT ONE OF THE PRESOURCE PACKS WAS STOCKED WITH RAY TECS THAT DO NOT WORK WITH OUR COUNTING SYSTEM. THIS IS THE FIRST ONE THAT I HAVE BEEN MADE AWARE OF AND NOT SURE HOW OFTEN THIS HAS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96243 PRESOURCE HYSTERECTOMY KIT OJF CARDINAL HEALTH 200, LLC SMA56LP20A 127147

    Patients

    Seq Age Sex Outcome Treatment
    1