BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22296122 · Received June 20, 2025

    Report

    Report Number
    9617229-2025-10220
    Event Type
    Injury
    Date Received
    June 20, 2025
    Date of Event
    May 27, 2025
    Report Date
    August 11, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628006942
    PMA / PMN Number
    P020056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: ¿ FOREIGN MATERIAL: NO OBSERVED ISSUE OR PIECE OF PLASTIC ON THE DEVICE. AS PER THE INVESTIGATION PROCEDURE, CREASES AND DEFORMATION WAS OBSERVED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A4, A5, 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 REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: FOREIGN MATERIAL ON IMPLANT.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "OPENED THIS IMPLANT AND THERE WAS A PIECE OF PLASTIC STUCK TO IT¿, NO PATIENT CONTACT. DEVICE WAS NOT IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "OPENED THIS IMPLANT AND THERE WAS A PIECE OF PLASTIC STUCK TO IT¿, NO PATIENT CONTACT. DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639470 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1251345 10888628006942

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female