BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR BREAST IMPLANT

    MDR report key: 21908873 · Received April 25, 2025

    Report

    Report Number
    21908873
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    April 14, 2025
    Report Date
    April 21, 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 CONFIRMED RUPTURED RIGHT BREAST IMPLANT. ORIGINAL PROCEDURE WAS IN [REDACTED]. PATIENT PRESENTS FOR IMPLANT REMOVAL. RUPTURED IMPLANT SENT TO PATHOLOGY PATHOLOGY: RECEIVED FOREIGN BODY RIGHT BREAST IMPLANT PREVIOUSLY DISRUPTED 235G 15.5X 10.7X 1.5CM SEMI TRANSLUCENT YELLOW-WHITE SYNTHETIC CAPSULE INSCRIBED WITH MENTOR [REDACTED] 250CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484478 MENTOR BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS LP

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female