BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR BREAST IMPLANT

    MDR report key: 22069095 · Received May 22, 2025

    Report

    Report Number
    22069095
    Event Type
    Malfunction
    Date Received
    May 22, 2025
    Date of Event
    April 15, 2025
    Report Date
    May 15, 2025
    Manufacturer
    MENTOR TEXAS LP
    Product Code
    MRD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERWENT A BREAST IMPLANT EXCHANGE S/P [STATUS POST] LEFT MASTECTOMY. THE REMOVED IMPLANT WAS DISCOID WHITE-OPAQUE SILICONE-LIKE CONSISTENT WITH INTACT BREAST IMPLANT, NO DEFECTS NOTED BUT FOCAL YELLOW STREAKS IDENTIFIED WITHIN THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2262333 MENTOR BREAST IMPLANT SIZER, MAMMARY, BREAST IMPLANT VOLUME MRD MENTOR TEXAS LP M+B

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Unknown