BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 120 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 8679123 · Received June 7, 2019

    Report

    Report Number
    9617229-2019-06761
    Event Type
    Injury
    Date Received
    June 7, 2019
    Date of Event
    May 9, 2019
    Report Date
    August 26, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL LATER REPORTED IMPLANT EXCHANGE DUE TO PATIENT'S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    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. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. THE REASON FOR REOPERATION IS "RIPPLING," "FEELS SMALLER AND ITS AS IF I CAN FEEL A PIECE OF PLASTIC ON THE BOTTOM LEFT SIDE, AND FEELS LIKE AN EMPTY ZIP LOCK BAG," AND "SILICONE IN THE LYMPH NODES."

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: CREASE FOLD, WEAR ABRASION, WHITE CALCIFICATION IN THE SURFACE OF THE SHELL, DEVICE APPEARANCE (OBSERVED 40 MM DARK PATCH EDGE MATERIAL INSIDE GEL DEVICE) AND WEIGHT TO THE SPEC. NO OPENINGS OBSERVED IN THE DEVICE. CLOUDY WAS OBSERVED AFTER AUTOCLAVE DISINFECTION PROCESS. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: NO ISSUES FOUND RELATED WITH THE MANUFACTURING PROCESS. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA.

    Description of Event or Problem · 1

    PATIENT REPORTED LEFT SIDE "RIPPLING," "FEELS SMALLER AND ITS AS IF THEY CAN FEEL A PIECE OF PLASTIC ON THE BOTTOM LEFT SIDE, AND FEELS LIKE AN EMPTY ZIP LOCK BAG, "SILICONE IN THE LYMPH NODES." DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    PATIENT REPORTED LEFT SIDE "RIPPLING," "FEELS SMALLER AND ITS AS IF THEY CAN FEEL A PIECE OF PLASTIC ON THE BOTTOM LEFT SIDE, AND FEELS LIKE AN EMPTY ZIP LOCK BAG, "SILICONE IN THE LYMPH NODES." HEALTHCARE PROFESSIONAL LATER REPORTED IMPLANT EXCHANGE DUE TO PATIENT'S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474487 STYLE 120 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1530085

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention