BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUI STYLE RHP SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22352140 · Received June 27, 2025

    Report

    Report Number
    9617229-2025-10778
    Event Type
    Injury
    Date Received
    June 27, 2025
    Report Date
    June 27, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    PREAMEND
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO D6A IMPLANT DATE: PARTIAL DATE 2018. THE EVENT OF "SEROMA-LATE" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ABBVIE 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: "INTRACAPSULAR RUPTURE"; "SUDDEN SEROMA OF MORE THAN 200CC."

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "INTRACAPSULAR RUPTURE AND SUDDEN SEROMA OF MORE THAN 200CC". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1855884 CUI STYLE RHP SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention