BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21108556 · Received January 8, 2025

    Report

    Report Number
    9617229-2025-00447
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    October 20, 2023
    Report Date
    May 29, 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

    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

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, D.6B, D9, H3, H6

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS RUPTURE, CYST(S) AND CALCIFICATION WAS RECEIVED ON APRIL 04, 2025, WITH CATALOG NUMBER 2914876. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: RUPTURE: NO OBSERVED. CALCIFICATION: NO OBSERVED. CYST(S): UNABLE TO OBSERVE SINCE IT IS A MEDICAL EVENT AND IS NOT RELATED TO THE DEVICE. AS PER THE INVESTIGATION PROCEDURE, CREASE AND DEFORMATION 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: H3, H6.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE RUPTURE AND "HARMLESS CALCIUM ALKATES". PATIENT ALSO REPORTED LEFT SIDE "INHOMOGENEOUS CYSTIC MASTOPATHY", WHICH IS NOT DEVICE-RELATED. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE RUPTURE AND "HARMLESS CALCIUM ALKATES". PATIENT ALSO REPORTED LEFT SIDE "INHOMOGENEOUS CYSTIC MASTOPATHY", WHICH IS NOT DEVICE-RELATED. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694538 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