BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 19700064 · Received July 9, 2024

    Report

    Report Number
    9617229-2024-16440
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    July 18, 2023
    Report Date
    March 3, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE WAS RECEIVED ON JULY 18, 2024, WITH LOT NUMBER 1250213. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: RUPTURE: OBSERVED, OPENING ASSESSED, AS FOLD FLAW OPENING. AS PER THE INVESTIGATION PROCEDURE: CREASE WEAR ABRASION NICK WAS COMPLETED. AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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: RUPTURE.

    Additional Manufacturer Narrative · 0

    CORRECTION TO G.3. AWARE DATE OF SUPPLEMENTAL MEDWATCH #1. AWARE DATE SHOULD HAVE BEEN LISTED AS 10/AUG/2024.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE "RUPTURE IMPLANT EXCHANGE". DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT-SIDE "RUPTURE IMPLANT EXCHANGE". DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT-SIDE "RUPTURE IMPLANT EXCHANGE". DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257089 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1250213

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Required Intervention