BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21977999 · Received May 7, 2025

    Report

    Report Number
    9617229-2025-07427
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    March 20, 2025
    Report Date
    June 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
    FL, 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. 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 2205424: 867672: BROKEN DEVICE. DEVICE RETURNED TO DEVICE ANALYSIS. 1508078: CAPSULAR CONTRACTURE. DEVICE NOT RETURNED TO DEVICE ANALYSIS. 2780987: NO COMPLAINT AGAINST THE DEVICE. DEVICE NOT RETURNED TO DEVICE ANALYSIS. THE SEARCH CRITERIA FOR THESE QUERIES ARE MENTIONED IN QPP07-01-004-HER1-G02 WORDING GUIDELINES FOR COMPLAINT INVESTIGATION CLOSURE AND REVISION 6.0. 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. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE WAS RECEIVED ON MAY 13, 2025 WITH LOT NUMBER 2205424. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE: OBSERVED AN OPENING ASSESSED AS FOLD FLAW OPENING. (TWO PATTERNS ALONG THE SAME EDGE) AND A MISSING PIECE OF SHELL ASSESSED AS INCONCLUSIVE. AS PER THE INVESTIGATION PROCEDURE, CREASES, WEAR ABRASION AND NON-PENETRATING NICK WERE COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    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

    HEALTHCARE PROFESSIONAL REPORTED "IMPLANT EXCHANGE AND RUPTURE" . THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "IMPLANT EXCHANGE AND RUPTURE." THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820700 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2205424

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention