BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 10871138 · Received November 19, 2020

    Report

    Report Number
    9617229-2020-19559
    Event Type
    Injury
    Date Received
    November 19, 2020
    Date of Event
    October 22, 2020
    Report Date
    December 31, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL ANALYSIS OF THE PHOTOS IDENTIFIED AN OPENING. DEVICE PATCH WITH LOT NUMBER 112652. DEVICE ANALYSIS PERFORMED THROUGH PHOTOGRAPHS, DUE TO THE IMPOSSIBILITY TO PERFORM MICROSCOPIC ANALYSIS AS IT WAS NOT POSSIBLE TO DETERMINE THE MOST LIKELY FAILURE MODE.

    Description of Event or Problem · 0

    THE DEVICE WAS EXPLANTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. REASON FOR REOPERATION: RUPTURE. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "MRI HAS DEMONSTRATED INTRACAPSULAR IMPLANT RUPTURE". PATIENT HAS BREAST CANCER, "ENHANCING MASS IN THE UPPER RIGHT BREAST DRAPES AROUND THE IMPLANT, AND PRESUMABLE REPRESENTS THE DESCRIBED CARCINOMA... THE MARGINS ARE IRREGULAR AND NODULAR", "PALPABLE MASS IN THE UPPER INNER RIGHT BREAST IS RATHER POORLY DEFINED AND QUITE EXTENSIVE", WHICH IS NOT DEVICE RELATED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336369 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 112652

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention