BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21108558 · Received January 8, 2025

    Report

    Report Number
    9617229-2025-00448
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    October 20, 2023
    Report Date
    May 30, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS LUMP/NODULE, GRANULOMA AND CYST(S) WAS RECEIVED ON APRIL 16, 2025 WITH LOT NUMBER 2914876. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: LUMP/NODULE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. GRANULOMA: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. CYST(S): UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. AS PER THE INVESTIGATION PROCEDURE, BROKEN AND DELAMINATION ON THE ORIENTATION DOT WERE OBSERVED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, H3, H6.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF "GRANULOMA" 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: "SUSPECTED SILICONOMAS"

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, B6, D6B, H6.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE "SUSPECTED SILICONOMAS" AND "HARMLESS CALCIUM ALKATES". PATIENT ALSO REPORTED RIGHT SIDE "MULTIPLE CYSTS" AND "SMALL PERIPROSTHETIC FIBROADENOMA", WHICH ARE NOT DEVICE-RELATED. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE "SUSPECTED SILICONOMAS" AND "HARMLESS CALCIUM ALKATES". PATIENT ALSO REPORTED RIGHT SIDE "MULTIPLE CYSTS" AND "SMALL PERIPROSTHETIC FIBROADENOMA", WHICH ARE NOT DEVICE-RELATED. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694540 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2914876

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention