BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 20349568 · Received October 2, 2024

    Report

    Report Number
    9617229-2024-21834
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    May 30, 2024
    Report Date
    November 25, 2024
    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

    LABORATORY ANALYSIS SUMMARY: THE DEVICE RELATED TO THE REPORTED EVENTS RUPTURE WAS RECEIVED ON OCTOBER 17, 2024, WITH LOT NUMBER 2903198. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: ¿ RUPTURE: OBSERVED OPENING ON THE POSTERIOR SIDE ASSESSED AS UNIDENTIFIED (TEAR) OPENING. (SHELL THICKNESS WITHIN SPECIFICATION). NO OTHER OBSERVATIONS OBSERVED, NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    PHOTO ANALYSIS: 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.

    Additional Manufacturer Narrative · 0

    CONTINUED SECTION E1: (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. REASON FOR REOPERATION: RUPTURE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2369728 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2903198

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention