BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 20838052 · Received December 3, 2024

    Report

    Report Number
    9617229-2024-25428
    Event Type
    Injury
    Date Received
    December 3, 2024
    Date of Event
    January 1, 2020
    Report Date
    December 3, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    -
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION IS: RUPTURE. LABORATORY ANALYSIS SUMMARY THE DEVICE RELATED TO THE REPORTED EVENT RUPTURE AND CREASE FOLDING OF IMPLANT WAS RECEIVED ON MARCH 26, 2024, WITH LOT NUMBER 3172872. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ¿ RUPTURE: NO OBSERVED OPENINGS ON THE DEVICE. ¿ CREASE FOLDING OF IMPLANT: OBSERVED CREASES ON THE DEVICE. ADDITIONAL OBSERVATIONS: ¿ NO OTHER OBSERVATIONS OBSERVED. NO FURTHER ACTIONS ARE REQUIRED AS THE DEVICE WAS IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL FURTHER REPORTED "RADIAL FOLDS¿. MRI CONFIRMED EVENTS. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050162 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3172872

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention