BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 10 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22123438 · Received June 2, 2025

    Report

    Report Number
    9617229-2025-08984
    Event Type
    Injury
    Date Received
    June 2, 2025
    Date of Event
    March 20, 2025
    Report Date
    July 22, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE II.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9 H3 H6. LABORATORY ANALYSIS SUMMARY- THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE AND CAPSULAR CONTRACTURE WAS RECEIVED ON JUN 05 , 2025, WITH LOT NUMBER 2020908. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: - RUPTURE: OBSERVED, BROKEN ASSESSED AS UNIDENTIFIED (TEAR) OPENING. - CAPSULAR CONTRACTURE: UNABLE TO OBSERVE SINCE IT IS A MEDICAL EVENT AND IS NOT RELATED TO THE DEVICE. NO ADDITIONAL OBSERVATIONS PERFORMED ON THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULE MODERATELY CONSTRICTED AND GRADE II". PATIENT UNDERGONE CAPSULECTOMY. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULE MODERATELY CONSTRICTED AND GRADE II". PATIENT UNDERGONE CAPSULECTOMY. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603714 STYLE 10 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2020908

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention