BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE OPEN HEART 2PART - PACK A

    MDR report key: 8413957 · Received March 11, 2019

    Report

    Report Number
    MW5084820
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Report Date
    February 26, 2019
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SEVERAL OCCURENCES OF BRAND NEW OPEN HEART PACKS (A) HAVING LARGE YELLOW SPOTS ON LAP SPONGES. MEDLINE AND COVIDIEN REPS CANNOT AGREE ON WHO IS AT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204063 MEDLINE OPEN HEART 2PART - PACK A GENERAL SURGERY TRAY LRO MEDLINE INDUSTRIES, INC. 18IBC432

    Patients

    Seq Age Sex Outcome Treatment
    1