BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 19294296 · Received May 10, 2024

    Report

    Report Number
    9617229-2024-08140
    Event Type
    Injury
    Date Received
    May 10, 2024
    Date of Event
    March 1, 2024
    Report Date
    June 4, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CORRECTED AND/OR CHANGED DATA: D1, S2A, D2B, D4, D9, H3, H4, H6. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE, EXPOSURE AND CANCER WAS RECEIVED ON JANUARY 08, 2025, WITH LOT NUMBER 3233695. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: CAPSULAR CONTRACTURE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE DEVICE. CANCER: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE DEVICE. EXPOSURE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE DEVICE. 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.

    Additional Manufacturer Narrative · 0

    THE EVENT OF FOREIGN BODY REACTION 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: FOREIGN BODY REACTION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CORRECTED AND/OR CHANGED DATA: A.2, B.3, B.5, D.3, G.1, H.6.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "DEVICE EXPOSURE". LATER, THE HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III." HEALTHCARE PROFESSIONAL ALSO REPORTED "PATIENT CURRENTLY UNDERGOING CHEMOTHERAPY FOR RIGHT BREAST CANCER¿, DEEMED NOT DEVICE RELATED. THIS RECORD IS FOR RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED, "DEVICE EXPOSURE". THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. THE AFFECTED SIDE IS UNKNOWN.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "DEVICE EXPOSURE". LATER THE HEALTHCARE PROFESSIONAL ALSO REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III, AND THE "PATIENT CURRENTLY UNDERGOING CHEMOTHERAPY FOR RIGHT BREAST CANCER¿. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. THIS RECORD RELATES TO THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971619 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3233695

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention