BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22879325 · Received August 22, 2025

    Report

    Report Number
    9617229-2025-14406
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    October 2, 2019
    Report Date
    August 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
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED E1 (PHONE NUMBER): (B)(6). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DHR TREND SUMMARY: THE REVIEW OF HISTORICAL COMPLAINTS ON THE COMPLAINT MANAGEMENT HANDLING SYSTEM IDENTIFIED THAT THERE WERE OTHER RECORDS FOR UNITS MANUFACTURED ON LOT NUMBER 2150713: 2340273: CAPSULAR CONTRACTURE. DEVICE NOT RETURNED TO DEVICE ANALYSIS. 2525056: RUPTURE. DEVICE RETURNED TO DEVICE ANALYSIS. 969853: CAPSULAR CONTRACTURE. DEVICE RETURNED TO DEVICE ANALYSIS. (B)(6): A0412 MATERIAL RUPTURE. DEVICE RETURNED TO DEVICE ANALYSIS. (B)(6): E2403 - NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, A25 - NO APPARENT ADVERSE EVENT. DEVICE NOT RETURNED TO DEVICE ANALYSIS. EVEN THOUGH THERE WERE 2 ADDITIONAL COMPLAINTS OF A0412 MATERIAL RUPTURE FOR THIS LOT NUMBER, THE DEVICES WERE RETURNED, AND AFTER INSPECTION NO WORKMANSHIP WERE DETECTED. THE SEARCH CRITERIA OF THESE QUERIES ARE MENTIONED ON QPP07-01-004-HER1-G02 (V6.0) THE REVIEW OF ALL POTENTIAL TREND EVALUATIONS FOR BREAST IMPLANTS CLOSED DURING THE PAST 12 MONTHS INDICATES THAT NO CONFIRMED COMPLAINT TRENDS HAVE BEEN OBSERVED FOR THE EVENT A0412 MATERIAL RUPTURE. 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: DEVICE RUPTURE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2657299 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 31 YR Female Required Intervention