BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 19448551 · Received June 3, 2024

    Report

    Report Number
    9617229-2024-09347
    Event Type
    Injury
    Date Received
    June 3, 2024
    Date of Event
    May 1, 2024
    Report Date
    October 8, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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.

    Additional Manufacturer Narrative · 0

    THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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: CAPSULAR CONTRACTURE BAKER GRADE IV.

    Additional Manufacturer Narrative · 0

    LABORATORY ANALYSIS SUMMARY: THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE WAS RECEIVED ON SEPTEMBER 05, 2024 WITH LOT NUMBER 1193136. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: CAPSULAR CONTRACTURE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. AS PER THE INVESTIGATION PROCEDURE DEFORMATION WAS COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO G.3. AWARE DATE OF SUPPLEMENTAL MEDWATCH #EMDR-(B)(4). AWARE DATE SHOULD HAVE BEEN LISTED AS 8/29/2024.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED ¿URGENT BREAST IMPLANT EXCHANGE FOR EARLY CAPSULAR CONTRACTURE BAKER GRADE IV¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE ¿URGENT BREAST IMPLANT EXCHANGE FOR EARLY CAPSULAR CONTRACTURE BAKER GRADE IV¿. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE ¿URGENT BREAST IMPLANT EXCHANGE FOR EARLY CAPSULAR CONTRACTURE BAKER GRADE IV¿. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE ¿URGENT BREAST IMPLANT EXCHANGE FOR EARLY CAPSULAR CONTRACTURE BAKER GRADE IV¿. THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE ¿URGENT BREAST IMPLANT EXCHANGE FOR EARLY CAPSULAR CONTRACTURE BAKER GRADE IV¿. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629693 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1193136

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention