BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 9219759 · Received October 22, 2019

    Report

    Report Number
    9617229-2019-13199
    Event Type
    Injury
    Date Received
    October 22, 2019
    Date of Event
    December 14, 2016
    Report Date
    October 22, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE REASON FOR REOPERATION: RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE IV. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. CLARIFICATION: LOT# 223019, CATALOG: 27-MM125-320.

    Description of Event or Problem · 1

    REGULATORY AGENCY PROVIDED THE FOLLOWING REPORT: PHYSICIAN REPORTED PAIN, CAPSULAR CONTRACTURE - BAKER GRADE IV, DISCOVERED VIA ULTRASOUND / MRI, A FLUID LEAKAGE, AND PERSPIRATION OF SILICON GEL OF THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012992 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 39 YR Required Intervention