BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 20 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 11522949 · Received March 19, 2021

    Report

    Report Number
    9617229-2021-05554
    Event Type
    Injury
    Date Received
    March 19, 2021
    Date of Event
    November 6, 2015
    Report Date
    March 19, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION CONTAINED IN THIS REPORT WAS PREVIOUSLY SUBMITTED THROUGH PSR ON 26/JAN/2016, 18/APR/2016 AND 25/JUL/2016. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENTS OF "CAPSULAR CONTRACTURE, CYST OR LUMP" ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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, CAPSULAR CONTRACTURE BAKER GRADE, DEVICE DIFFERENT SHAPE AND MIGRATING TOWARDS THE ARM, CYST OR LUMP¿.

    Description of Event or Problem · 1

    PATIENT REPORTED LEFT SIDE IMPLANT "IS A DIFFERENT SHAPE AND MIGRATING TOWARDS THE ARM", RUPTURE, AND A "CYST OR LUMP" UNDERNEATH THE LEFT BREAST." ADDITIONAL REPORT OF LEFT SIDE, "SOFTER THAN NORMAL", AND CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424260 STYLE 20 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1462305

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention