BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 20456666 · Received October 15, 2024

    Report

    Report Number
    9617229-2024-22668
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    September 11, 2024
    Report Date
    January 27, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED E.1 PHONE NUMBER: (B)(6). 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. THE REASON FOR REOPERATION: RUPTURE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CORRECTED AND/OR CHANGED DATA: D9, H3, H6. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE WAS RECEIVED ON JANUARY 29, 2025 WITH LOT NUMBER 2895853. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE: OBSERVED BROKEN DEVICE ASSESSED AS UNIDENTIFIED (TEAR) OPENING (SHELL THICKNESS WITHIN SPECIFICATION). AS PER THE INVESTIGATION PROCEDURE CREASES WERE 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

    PHOTO ANALYSIS RESULTS: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. NO ADDITIONAL OBSERVATIONS ARE PERFORMED. NO FURTHER ACTIONS ARE REQUIRED AS NO MANUFACTURING ISSUES ARE OBSERVED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE" DIAGNOSED VIA MAMMOGRAPHY AND ULTRASOUND. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED INTRACAPSULAR RUPTURE DIAGNOSED VIA COMBINED MAMMOGRAPHY AND ULTRASOUND. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED INTRACAPSULAR RUPTURE DIAGNOSED VIA COMBINED MAMMOGRAPHY AND ULTRASOUND. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425865 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2895853

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention