BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21786605 · Received April 7, 2025

    Report

    Report Number
    9617229-2025-05632
    Event Type
    Injury
    Date Received
    April 7, 2025
    Date of Event
    September 20, 2024
    Report Date
    April 7, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, H3, H6. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE WAS RECEIVED ON JUNE 17, 2025, WITH LOT NUMBER 2864690. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: ¿ RUPTURE: OBSERVED BROKEN DEVICE ASSESSED AS UNIDENTIFIED (TEAR) OPENING AND MISSING PIECE OF SHELL ASSESSED AS INCONCLUSIVE. NO ADDITIONAL OBSERVATIONS PERFORMED ON THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    CONTINUED: E.1. PHONE NUMBER: (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. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570158 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2864690

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention