BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 12335830 · Received August 18, 2021

    Report

    Report Number
    12335830
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 21, 2021
    Report Date
    August 10, 2021
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OHG
    UDI-DI
    10884389542040
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING CIRCUMCISION, METAL SHAVINGS FLAKED OFF THE HEMOSTATS, FROM MEDLINE INDUSTRIES, INC. CIRCUMCISION TRAY, TO THE PATIENT DURING A STERILE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235162 MEDLINE INDUSTRIES, INC. CIRCUMCISION TRAY OHG MEDLINE INDUSTRIES, INC. DYNDF1072A 21EBB656 10884389542040

    Patients

    Seq Age Sex Outcome Treatment
    1