BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR BREAST IMPLANT

    MDR report key: 22769801 · Received August 11, 2025

    Report

    Report Number
    22769801
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    August 5, 2025
    Report Date
    August 6, 2025
    Manufacturer
    MENTOR TEXAS LP
    Product Code
    FTR
    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 WITH ONGOING BREAST PAIN. FOUND TO HAVE BILATERAL IMPLANT RUPTURE ON MRI. SCHEDULED FOR IMPLANT EXCHANGE. PATHOLOGY RIGHT BREAST-RECEIVED RUPTURED BREAST IMPLANT 14X12X3.5CM MENTOR [REDACTED] 325CC LEFT BREAST IMPLANT - RECEIVED RUPTURED BREAST IMPLANT MEASURING 15X 14X 3CM RUPTURE SITE IS 0.3CM GREATEST DIMENSION. MENTOR [REDACTED] 325CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2183246 MENTOR BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS LP

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female