BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR BREAST IMPLANT

    MDR report key: 22193843 · Received June 12, 2025

    Report

    Report Number
    22193843
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Date of Event
    May 13, 2025
    Report Date
    June 6, 2025
    Manufacturer
    MENTOR TEXAS LP
    Product Code
    MRD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT FOUND TO HAVE LEFT BREAST IMPLANT RUPTURE ON MRI FINDINGS. SCHEDULED FOR BILATERAL IMPLANT EXCHANGE. UNKNOWN WHEN THESE WERE ORIGINALLY IMPLANTED. IMPLANT SENT TO PATHOLOGY. MENTOR WORLDWIDE, [REDACTED]- 450CC, 441G 13.0X13.0X 4.5CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361933 MENTOR BREAST IMPLANT SIZER, MAMMARY, BREAST IMPLANT VOLUME MRD MENTOR TEXAS LP

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female