BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 20001919 · Received August 20, 2024

    Report

    Report Number
    9617229-2024-19137
    Event Type
    Injury
    Date Received
    August 20, 2024
    Date of Event
    June 12, 2024
    Report Date
    August 20, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED E1: 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.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE WAS RECEIVED ON APRIL 16, 2025, WITH LOT NUMBER 2964721. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: ¿ RUPTURE: OBSERVED BROKEN ASSESSED AS UNIDENTIFIED (TEAR) OPENING (SHELL THICKNESS WITHIN SPECIFICATION). AS PER THE INVESTIGATION PROCEDURES CREASES WERE COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED, IMPLANT RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED ANOTHER MANUFACTURER'S DEVICE. THIS RELATES TO THE RIGHT SIDE.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED IMPLANT RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED ANOTHER MANUFACTURER'S DEVICE. THIS RELATES TO THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2395788 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2964721

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention