BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 18430437 · Received January 2, 2024

    Report

    Report Number
    9617229-2024-00062
    Event Type
    Injury
    Date Received
    January 2, 2024
    Date of Event
    March 23, 2022
    Report Date
    February 1, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED PHONE NUMBER(S) (E.1): (B)(6). 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 FOR REOPERATION IS: RUPTURE.

    Additional Manufacturer Narrative · 0

    PHOTO ANALYSIS VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: DEVICE PATCH WITH LOT NUMBER 2923121 AND CATALOG NUMBER 115-290. RUPTURE- BREAST: OBSERVED, OPENING ON THE DEVICE BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. CREASES/FOLDING OF IMPLANT- BREAST: NOT OBSERVED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED, VIA MRI, RIGHT SIDE "HAVE SOME CREPES INSIDE THE BREAST IMPLANT, NO CREPES ON OUTSIDE" AND RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED, VIA MRI, RIGHT SIDE "HAVE SOME CREPES INSIDE THE BREAST IMPLANT, NO CREPES ON OUTSIDE" AND RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607005 STYLE 115 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2923121

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Female Required Intervention