BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 16938277 · Received May 16, 2023

    Report

    Report Number
    16938277
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    April 27, 2023
    Report Date
    April 28, 2023
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OJU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MANUFACTURER HAS CHANGED THIS PRODUCT FROM STERILE TO NON-STERILE USING THAT PACKAGING & MANUFACTURER REFERENCE NUMBER MANUFACTURER RESPONSE FOR GENERAL SURGERY TRAY, MEDLINE INDUSTRIES, INC. (PER SITE REPORTER) THEY ARE INVESTIGATING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2188967 MEDLINE INDUSTRIES, INC. SKIN PREP TRAY OJU MEDLINE INDUSTRIES, INC. DYNDA2232A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown