BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 110 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21151962 · Received January 14, 2025

    Report

    Report Number
    9617229-2025-00791
    Event Type
    Injury
    Date Received
    January 14, 2025
    Date of Event
    December 9, 2024
    Report Date
    August 8, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, H3, H6. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT SEROMA-LATE AND RUPTURE WAS RECEIVED ON APRIL 03, 2025. WITH LOT NUMBER 2231691. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE - SEROMA-LATE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. - RUPTURE: NOT OBSERVED. AS PER THE INVESTIGATION PROCEDURE, CREASES, DEFORMATION 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B3, B5, D1, D2A, D2B, D4, D.6A, D6B, H4, H6 A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    PATIENT REPORTED A RUPTURE. LATER REPRESENTATIVE REPORTED "RUPTURE AND SEROMA." THIS RECORD REPRESENTS THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED A RUPTURE. LATER REPRESENTATIVE REPORTED "RUPTURE AND SEROMA." THIS RECORD REPRESENTS THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED, IT IS UNKNOWN IF IT WAS REPLACED.

    Description of Event or Problem · 0

    PATIENT REPORTED A RUPTURE TO AN UNKNOWN SIDE. THIS RECORD REPRESENTS THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED A RUPTURE TO AN UNKNOWN SIDE. THIS RECORD REPRESENTS THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516270 STYLE 110 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2231691

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention