BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21005945 · Received December 23, 2024

    Report

    Report Number
    9617229-2024-26709
    Event Type
    Injury
    Date Received
    December 23, 2024
    Report Date
    May 19, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OF "CAPSULAR CONTRACTURE" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ABBVIE IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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: CAPSULAR CONTRACTURE, RUPTURE.

    Additional Manufacturer Narrative · 0

    VISUAL ANALYSIS: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: ¿ CAPSULAR CONTRACTURE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED SINCE NO ISSUE IN THE MANUFACTURING OF THE DEVICE IS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A2, A4, A5, B1, B5, H6.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9 H3 H6. LABORATORY ANALYSIS SUMMARY THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE WAS RECEIVED ON APRIL 03, 2025, WITH LOT NUMBER 2912367. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: CAPSULAR CONTRACTURE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE DEVICE. AS PER THE INVESTIGATION PROCEDURES OBSERVED AN OPENING, WEAR ABRASION AND CREASES WERE COMPLETED 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

    PATIENT REPORTED "RUPTURE, CAPSULAR CONTRACTURE". THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE "RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". HEALTHCARE PROFESSIONAL LATER REPORTED "REMOVAL DUE TO PROSTHESIS RUPTURED FOR LEFT SIDE". DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE "RUPTURE, CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN. HEALTHCARE PROFESSIONAL LATER REPORTED THE PREVIOUSLY REPORTED EVENT OF "RUPTURE" OCCURRED ON THE CONTRA-LATERAL SIDE AND WILL BE UNREPORTED FOR DEVICE ON RECORD. THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED "RUPTURE, CAPSULAR CONTRACTURE". HEALTHCARE PROFESSIONAL LATER REPORTED "REMOVAL DUE TO PROSTHESIS RUPTURED FOR LEFT SIDE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2624098 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2912367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention