BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 12146199 · Received July 9, 2021

    Report

    Report Number
    9617229-2021-47140
    Event Type
    Injury
    Date Received
    July 9, 2021
    Date of Event
    June 10, 2021
    Report Date
    September 24, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: "THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE WAS RECEIVED ON (B)(6)2021 WITH LOT NUMBER 1760592. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: BROKEN SHELL, UNDERWEIGHT, AROUND 0-25% OF THE SHELL IS MISSING, FOLD CREASES. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED; BROKEN SHELL WITH SHARP EDGE IN THE SAME LOCATION OF CREASE ASSESSED AS FOLD FLAW OPENING AND STRESS MARKS ASSESSED AS NON PENETRATING NICKS. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: - BROKEN SHELL WITH SHARP EDGE IN THE SAME LOCATION OF CREASE ASSESSED AS FOLD FLAW OPENING."

    Description of Event or Problem · 0

    DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. 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. REASON FOR REOPERATION: RUPTURE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040115 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1760592

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention