BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 8623900 · Received May 20, 2019

    Report

    Report Number
    9617229-2019-04592
    Event Type
    Injury
    Date Received
    May 20, 2019
    Report Date
    May 20, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REASON FOR REOPERATION IS INFLAMMATION/IRRITATION. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION:VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: WEIGHT TO THE SPECTRUM, FLAT CREASE, BLACK PARTICLES, AND DEFORMATION. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: THERE WERE NO ISSUES RELATED WITH THE MANUFACTURING PROCESS. THE EVENT OF INFLAMMATION IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED "LEFT SIDE INFLAMMATION RESPONSE". THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419545 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3019791

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention