BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22029068 · Received May 15, 2025

    Report

    Report Number
    9617229-2025-07995
    Event Type
    Injury
    Date Received
    May 15, 2025
    Date of Event
    January 1, 2024
    Report Date
    July 2, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    5060191607636
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS OF RUPTURE WAS RECEIVED ON MAY 20, 2025, WITH LOT NUMBER 3200798. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: RUPTURE: OBSERVED AN OPENING ASSESSED AS AN UNIDENTIFIED (TEAR) OPENING. NO ADDITIONAL OBSERVATIONS PERFORMED ON THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A6, D9, H3, H6.

    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(S) FOR REOPERATION IS/ARE: RUPTURE. CLARIFICATION TO PARTIAL B3 IMPLANT DATE: 2024 WAS PROVIDED. CONTINUED E1 PHONE NUMBER: (B)(6).

    Description of Event or Problem · 0

    HEALTHCARE PROVIDER REPORTED A RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURERS DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROVIDER REPORTED A RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURERS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011137 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3200798 5060191607636

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention