BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 9971765 · Received April 17, 2020

    Report

    Report Number
    9971765
    Event Type
    Malfunction
    Date Received
    April 17, 2020
    Date of Event
    March 4, 2020
    Report Date
    April 7, 2020
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN OPENING NEW TOTAL JOINT PACK (MEDLINE INDUSTRIES INC. STERILE TOTAL JOINT SURGICAL TRAY), GOWN FOUND TO HAVE BROWN STREAKS (BROWN PARTICLES) ON VELCRO. PRODUCT NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434952 MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAY LRO MEDLINE INDUSTRIES, INC. DYNJ23149K 20AMC493

    Patients

    Seq Age Sex Outcome Treatment
    1