BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21969860 · Received May 6, 2025

    Report

    Report Number
    9617229-2025-07346
    Event Type
    Injury
    Date Received
    May 6, 2025
    Date of Event
    April 11, 2024
    Report Date
    July 29, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    5060191606783
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED: E1- PHONE NUMBER: (B)(6). 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.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS RUPTURE WAS RECEIVED ON JUN 03, 2025, WITH LOT NUMBER 3133819. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: RUPTURE: OBSERVED AN OPENING ASSESSED AS SURGICAL DAMAGE , OBSERVED BROKEN DEVICE ASSESSED AS UNIDENTIFIED (TEAR) OPENING AND OBSERVED A MISSING PIECE OF SHELL ASSESSED AS INCONCLUSIVE. NO ADDITIONAL OBSERVATIONS PERFORMED ON THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEVICE RUPTURE, FOLDS AND SOME SURROUNDING FLUID DIAGNOSED BY ULTRASOUND AND MAMMOGRAPHY. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98408 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2282830 5060191606783

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention