BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 25174523 · Received May 14, 2026

    Report

    Report Number
    9617229-2026-09012
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    April 16, 2025
    Report Date
    May 14, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A2, A4, A5, A6, B3, B5, B6.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCE'S NOTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: RUPTURE.

    Description of Event or Problem · 0

    PATIENT REPORTED OF THE LEFT SIDE DEVICE: "RUPTURE". LATER PATIENT REPORTED "PROBLEMS WHEN I LIE ON MY SIDE. STABBING SENSATION". THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED OF THE LEFT SIDE DEVICE: "RUPTURE". THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66351 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2836836

    Patients

    Seq Age Sex Outcome Treatment
    1