BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21392636 · Received February 18, 2025

    Report

    Report Number
    9617229-2025-02698
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    December 19, 2024
    Report Date
    March 19, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONT E1 PHONE NUMBER- (B)(6). PHOTO ANALYSIS- VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: ¿ RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, H3, H6. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS CAPSULAR CONTRACTURE AND RUPTURE WAS RECEIVED ON MARCH 19, 2025 WITH LOT NUMBER 3003404. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: - CAPSULAR CONTRACTURE: UNABLE TO OBSERVE. - 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-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.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED BROKEN PROSTHESES. PHYSICIAN LATER REPORTED RUPTURE AND CAPSULAR CONTRACTURE BAKER I. THIS RECORD CREATED FOR RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH NON-ABBVIE DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED BROKEN PROSTHESES. HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE AND CAPSULAR CONTRACTURE, BAKER GRADE I. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED BROKEN PROSTHESES. HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE AND CAPSULAR CONTRACTURE, BAKER GRADE I. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623667 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3003404

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention