BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 18993337 · Received March 28, 2024

    Report

    Report Number
    9617229-2024-05381
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    February 14, 2024
    Report Date
    April 15, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 APRIL 22, 2024, WITH LOT NUMBER 2905786. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE: OBSERVED AN OPENING ON POSTERIOR ASSESSED AS A SURGICAL IMPACT OPENING. (SHELL THICKNESS WITHIN SPEC). ADDITIONAL OBSERVATIONS: NON-PENETRATING NICK OBSERVED ON THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED AS THE DEVICE WAS IMPLANTED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO G.3. AWARE DATE OF SUPPLEMENTAL MEDWATCH #2. AWARE DATE SHOULD HAVE BEEN LISTED AS 21MAY2024.

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. REASON FOR REOPERATION: RUPTURE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE, CONFIRMED VIA MAMMOGRAM. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE, CONFIRMED VIA MAMMOGRAM. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027833 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2905786

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention