BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 20 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 19931634 · Received August 7, 2024

    Report

    Report Number
    9617229-2024-18369
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    July 9, 2024
    Report Date
    September 17, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: RUPTURE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: H6. LABORATORY ANALYSIS SUMMARY: DEVICE PHOTOGRAPH(S) FOR THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE WAS REQUESTED ON AUGUST 207, 2024. IT IS NOT POSSIBLE TO DETERMINE THE LOT NUMBER OR CATALOG NUMBER THROUGH THE PHOTOS PROVIDED. VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. NO ADDITIONAL OBSERVATIONS ARE PERFORMED. NO FURTHER ACTIONS ARE REQUIRED AS NO MANUFACTURING ISSUES ARE OBSERVED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR A LEFT SIDE. DEVICE WAS EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR A LEFT SIDE. THE DEVICE WAS EXPLANTED, REPLACED AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220672 STYLE 20 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1265772

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention