BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22747509 · Received August 8, 2025

    Report

    Report Number
    9617229-2025-13413
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    May 19, 2025
    Report Date
    September 24, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9 H3 H6. LABORATORY ANALYSIS SUMMARY: THE DEVICE RELATED TO THE REPORTED EVENTS RUPTURE WAS RECEIVED ON AUGUST 13, 2025, WITH LOT NUMBER 3133851. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: ¿ RUPTURE: OBSERVED BROKEN DEVICE ASSESSED AS UNIDENTIFIED (TEAR) OPENING NO ADDITIONAL OBSERVATIONS PERFORMED ON THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" DIAGNOSED VIA MAMMOGRAPHY. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" DIAGNOSED VIA MAMMOGRAPHY. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497837 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3133851

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention