BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22467357 · Received July 10, 2025

    Report

    Report Number
    9617229-2025-11496
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    May 22, 2025
    Report Date
    July 10, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED: E.1. PHONE NUMBER: (B)(6). 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, H3, H6. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS RUPTURE WAS RECEIVED ON (B)(6) 2025 WITH LOT NUMBER 2150713. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: RUPTURE: OBSERVED AN OPENING ASSESSED AS SURGICAL IMPACT OPENING. AS PER THE INVESTIGATION PROCEDURE, CREASES AND NON PENETRATING NICKS WERE OBSERVED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RUPTURE CONFIRMED BY ULTRASOUND. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729813 STYLE 115 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2150713

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention