BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 20494607 · Received October 21, 2024

    Report

    Report Number
    9617229-2024-22964
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    May 29, 2024
    Report Date
    January 21, 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

    VISUAL ANALYSIS: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: ¿ RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. ¿ CAPSULAR CONTRACTURE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. NO ADDITIONAL OBSERVATIONS ARE PERFORMED. NO FURTHER ACTIONS ARE REQUIRED AS NO MANUFACTURING ISSUES ARE OBSERVED.

    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. THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN 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: RUPTURE AND CAPSULAR CONTRACTURE, BAKER GRADE III.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A2, A3A, D9, H3, H6. LABORATORY ANALYSIS SUMMARY: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE AND CAPSULAR CONTRACTURE WAS RECEIVED ON DECEMBER 04, 2024 WITH LOT NUMBER 2070778. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE: OBSERVED BROKEN DEVICE ASSESSED AS FOLD FLAW OPENING. CAPSULAR CONTRACTURE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. AS PER THE INVESTIGATION PROCEDURE CREASES AND WEAR ABRASION 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

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEVICE RUPTURE AND CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEVICE RUPTURE AND CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEVICE RUPTURE AND CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960687 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2070778

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention