BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 8945643 · Received August 29, 2019

    Report

    Report Number
    9617229-2019-12456
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    April 15, 2019
    Report Date
    December 13, 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

    THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE WAS RECEIVED ON NOVEMBER 01, 2019 WITH LOT NUMBER 2911625. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: DEFORMATION DEVICE, CREASES FOLD AND WEIGHT TO THE SPECIFICATION. CLOUDY, BUBBLES AND VOIDS IN THE GEL OBSERVED AFTER AUTOCLAVE CYCLE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: NO ISSUES FOUND RELATED WITH THE MANUFACTURING PROCESS.

    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. REASON FOR REOPERATION: CAPSULAR CONTRACTURE BAKER GRADE III. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738372 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2911625

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention