BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 10476933 · Received September 1, 2020

    Report

    Report Number
    9617229-2020-13621
    Event Type
    Injury
    Date Received
    September 1, 2020
    Date of Event
    July 15, 2020
    Report Date
    November 6, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED RED, YELLOW PARTICLE MATERIALS ON THE SHELL AND AN OPENING (ON ANTERIOR AND POSTERIOR SIDE). DEVICE PATCH WITH LOT NUMBER 3001347 AND CATALOG NUMBER MX 325G. DEVICE ANALYSIS PERFORMED THROUGH PHOTOGRAPHS, DUE TO THE IMPOSSIBILITY TO PERFORM MICROSCOPIC ANALYSIS AS IT IS NOT POSSIBLE TO DETERMINE THE MOST LIKELY FAILURE MODE.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE RUPTURE. MRI AND ULTRASOUND PERFORMED. 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

    PATIENT REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939923 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3001347

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention