BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 20781148 · Received November 26, 2024

    Report

    Report Number
    9617229-2024-25019
    Event Type
    Injury
    Date Received
    November 26, 2024
    Date of Event
    September 10, 2023
    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

    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. LATE EMDR SUBMITTED PER CAPA:679110. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE/CAPSULAR CONTRACTURE WAS RECEIVED ON APRIL 10, 2024, WITH LOT NUMBER 2190658. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE: OBSERVED, BROKEN DEVICE ASSESSED AS SURGICAL IMPACT OPENING. (SHELL THICKNESS WAS WITHIN SPECIFICATION). AND MISSING PIECE OF SHELL ASSESSED AS INCONCLUSIVE. CAPSULAR CONTRACTURE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ADDITIONAL OBSERVATIONS: STRESS MARKS OBSERVED. NO FURTHER ACTIONS ARE REQUIRED AS NO MANUFACTURING ISSUES ARE OBSERVED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED IMPLANT RUPTURE DISCOVERED BY X-RAY AND CAPSULAR CONTRACTURE, BAKER GRADE I, ON THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2573913 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2190658

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention