BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21316187 · Received February 5, 2025

    Report

    Report Number
    9617229-2025-02025
    Event Type
    Injury
    Date Received
    February 5, 2025
    Date of Event
    January 14, 2025
    Report Date
    March 26, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIVING ADDITIONAL INFORMATION, PATIENT REPORTED THAT "THE TESTS SHOWED NO RUPTURE". HENCE UNREPORTING THE PREVIOUSLY REPORTED RUPTURE. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5.

    Additional Manufacturer Narrative · 0

    CLARIFICATION D4: LEFT: N-TSF385/ 2990840 / NI RIGHT: N-TSF385 / 3008092 / NI. 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.

    Description of Event or Problem · 0

    UPON RECEIVING ADDITIONAL INFORMATION, PATIENT REPORTED THAT "THE TESTS SHOWED NO RUPTURE". HENCE UNREPORTING THE PREVIOUSLY REPORTED RUPTURE.

    Description of Event or Problem · 0

    PATIENT REPORTED RUPTURE, AFFECTED SIDE UNKNOWN. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896477 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2990840

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention