BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 23507380 · Received November 9, 2025

    Report

    Report Number
    9617229-2025-19327
    Event Type
    Injury
    Date Received
    November 9, 2025
    Date of Event
    October 5, 2025
    Report Date
    November 9, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    5060191601474
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTO ANALYSISL: DEVICE LOT NUMBER 3150347 WAS OBSERVED. VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: ¿ RUPTURE: OBSERVED, OPENING ON THE DEVICE BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. NO FURTHER ACTIONS ARE REQUIRED SINCE NO ISSUE IN THE MANUFACTURING OF THE DEVICE IS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES 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: "SUSPECTED RUPTURE".

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "SUSPECTED RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1781923 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3150347 5060191601474

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention