BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 6215599 · Received December 30, 2016

    Report

    Report Number
    6215599
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Date of Event
    December 5, 2016
    Report Date
    December 8, 2016
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MAYO STAND COVERS IN THE MAJOR BASIN PACKS ARE FUSED TOGETHER. WE ARE PULLING INDIVIDUAL MAYO STAND COVERS FROM THE SHELF AND DISCARDING THE ONES THAT ARE FUSED TOGETHER TO HAVE PRODUCT TO USE FOR SURGICAL CASES. THE OPERATING ROOM CLINICAL SUPERVISOR HAS SPOKEN WITH THE CARDINAL REP, (B)(4), AND SHE WAS MADE AWARE OF OUR ISSUE WITH THE MAYO STAND COVERS. MANUFACTURER RESPONSE FOR MAYO STAND COVER, MAYO STAND COVER (PER SITE REPORTER): REP NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866641 CARDINAL HEALTH GENERAL SURGERY TRAY LRO CARDINAL HEALTH 200, LLC SUT21MBARD

    Patients

    Seq Age Sex Outcome Treatment
    1 NO