BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 10654760 · Received October 9, 2020

    Report

    Report Number
    9617229-2020-07761
    Event Type
    Injury
    Date Received
    October 9, 2020
    Date of Event
    July 2, 2017
    Report Date
    October 9, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALLERGAN DID NOT SUBMIT THIS MDR WITHIN 30 DAYS OF BECOMING AWARE. RECENT STIMULATED REPORTING RELATED TO 2011068-7/2/19-001-R HAS INCREASED COMPLAINT AND MDR VOLUME. ALLERGAN IS IMPLEMENTING A PLAN TO ADDRESS THE INCREASED VOLUMES. IN RESPONSE TO FDA REPORT NUMBER MW 5090755. 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 GRADE UNKNOWN.

    Description of Event or Problem · 1

    PATIENT REPORTED VIA REGULATORY AGENCY "BREAST CONTRACTURE THAT WORSENED", BAKER GRADE UNKNOWN, AND "INFLAMMATION ALL OVER." PATIENT ALSO REPORTED VIA REGULATORY AGENCY "JOINT PAIN", "HEALTH STARTED WITH BREAKOUT", HAIR LOSS, WEIGHT LOSS, "SLOWER HEALING", "MEMORY AND VISION QUICKLY WORSENED"; THESE ARE NOT DEVICE RELATED. DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121956 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention