BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 16582028 · Received March 21, 2023

    Report

    Report Number
    16582028
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    March 10, 2023
    Report Date
    March 13, 2023
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    FTN
    UDI-DI
    10195327244736
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    MID 30¿S FEMALE WITH HISTORY OF BILATERAL MACROMASTIA. PROCEDURE: BILATERAL REDUCTION MAMMOPLASTY. WHEN THE PLASTIC MAJOR PACK WAS OPENED FOR USE, THERE WAS A HARD, BROWN DEBRIS IN THE PACKAGE. NOT USED ON THE PATIENT. NO KNOWN HARM. MANUFACTURER RESPONSE FOR PLASTIC SURGERY AND ACCESSORIES KIT, MEDLINE INDUSTRIES, INC. (PER SITE REPORTER) WILL LOOK INTO IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12383 MEDLINE INDUSTRIES, INC. PLASTIC SURGERY AND ACCESSORIES KIT FTN MEDLINE INDUSTRIES, INC. DYNJ82842A 22JBJ989 10195327244736

    Patients

    Seq Age Sex Outcome Treatment
    1 13140 DA Female