BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21743810 · Received April 1, 2025

    Report

    Report Number
    9617229-2025-05281
    Event Type
    Injury
    Date Received
    April 1, 2025
    Date of Event
    January 13, 2025
    Report Date
    June 4, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON(S) FOR REOPERATION IS/ARE: CONTRA-LATERAL SIDE RUPTURE AND LATER CAPSULAR CONTRACTURE BAKER GRADE IV. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A5, B3, D9, H3, H6. LABORATORY ANALYSIS SUMMARY: THE DEVICE RELATED TO THE REPORTED EVENTS CAPSULAR CONTRACTURE WAS RECEIVED ON APRIL 29, 2025, WITH LOT NUMBER 2031927. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: ¿ CAPSULAR CONTRACTURE: 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 Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B.5., D6B., H.6.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE IMPLANT EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. LATER, A CAPSULAR CONTRACTURE BAKER GRADE IV WAS REPORTED AND CONFIRMED BY PHYSICIAN'S OFFICE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE IMPLANT EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. LATER, A CAPSULAR CONTRACTURE BAKER GRADE IV WAS REPORTED AND CONFIRMED BY PHYSICIAN'S OFFICE. DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954338 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2031927

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention