BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21998771 · Received May 9, 2025

    Report

    Report Number
    9617229-2025-07673
    Event Type
    Injury
    Date Received
    May 9, 2025
    Date of Event
    March 29, 2021
    Report Date
    May 14, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT TO A MEDWATCH SUBMITTED UNDER MANUFACTURE REPORT NUMBER 9617229-2025-0000094. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE WAS RECEIVED ON MARCH 27, 2025, WITH LOT NUMBER 1778909. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: CAPSULAR CONTRACTURE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. AS PER THE INVESTIGATION PROCEDURE CREASE DEFORMATION WAS COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED. THE EVENT OF "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN" 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: CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN.

    Additional Manufacturer Narrative · 0

    CORRECTION TO G.3. AWARE DATE OF INITIAL MEDWATCH: AWARE DATE SHOULD HAVE BEEN LISTED AS 4/14/2025.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. PATIENT LATER REPORTED "NO COMPLAINTS AGAINST THE DEVICE". HEALTHCARE PROFESSIONAL LATER REPORTED "CONTRACTURE". DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. PATIENT LATER REPORTED "NO COMPLAINTS AGAINST THE DEVICE". HEALTHCARE PROFESSIONAL LATER REPORTED "CONTRACTURE". DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230633 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1778909

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention