BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21866089 · Received April 18, 2025

    Report

    Report Number
    9617229-2025-06434
    Event Type
    Injury
    Date Received
    April 18, 2025
    Date of Event
    January 1, 2014
    Report Date
    April 18, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS OF RUPTURE WAS RECEIVED ON APRIL 29, 2025, WITH LOT NUMBER 230286. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: ¿ RUPTURE: OBSERVED AN OPENING ASSESSED AS FOLD FLAW OPENING. AS PER THE INVESTIGATION PROCEDURE, CREASES AND WEAR ABRASION WERE OBSERVED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCE'S 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.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT-SIDE "IMPLANT EXCHANGE AND CAPSULECTOMY" AND "RIGHT CAPSULAR CONTRACTURE, BAKER GRADE II". HEALTHCARE PROFESSIONAL LATER CONFIRMED "EXCHANGE OF A TEXTURED DEVICE DUE TO PRODUCT CONCERN" AND "CAPSULAR CONTRACTURE BAKER GRADE II". HEALTHCARE PROFESSIONAL LATER ALSO REPORTED IMPLANT WAS NOTED "RUPTURED" UNDER OBSERVATIONS DURING SURGERY. DEVICE WAS EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT-SIDE "IMPLANT EXCHANGE AND CAPSULECTOMY" AND "RIGHT CAPSULAR CONTRACTURE, BAKER GRADE II". HEALTHCARE PROFESSIONAL LATER CONFIRMED "EXCHANGE OF A TEXTURED DEVICE DUE TO PRODUCT CONCERN" AND "CAPSULAR CONTRACTURE BAKER GRADE II". HEALTHCARE PROFESSIONAL LATER ALSO REPORTED IMPLANT WAS NOTED "RUPTURED" UNDER OBSERVATIONS DURING SURGERY. DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1732655 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 230286

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention