BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 12044150 · Received June 22, 2021

    Report

    Report Number
    9617229-2021-46146
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    January 15, 2021
    Report Date
    August 4, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE WAS RECEIVED ON (B)(6) 2021, WITH LOT NUMBER 2180346. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED, WEIGHT TO THE SPEC, CREASE FOLD, WHITE PARTICLES ON THE SURFACE OF THE SHELL, DEFORMATION. CLOUDY WAS OBSERVED, AFTER AUTOCLAVE DISINFECTION PROCESS. BASED ON THE DEVICE ANALYSIS, THE FINAL ASSESSMENT IS: NO ISSUES FOUND RELATED WITH THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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: CAPSULAR CONTRACTURE, BAKER IV.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941850 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2180346

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention