BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 18623919 · Received February 1, 2024

    Report

    Report Number
    9617229-2024-01796
    Event Type
    Injury
    Date Received
    February 1, 2024
    Date of Event
    January 1, 2023
    Report Date
    December 19, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    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. THE REASON FOR REOPERATION: RUPTURE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ¿ RUPTURE : OBSERVED, OPENING ASSESSED AS UNIDENTIFIED (TEAR) . (SHELL THICKNESS WAS WITHIN SPECIFICATION). NO ADDITIONAL OBSERVATION.

    Additional Manufacturer Narrative · 0

    VISUAL EVALUATION:DEVICE PHOTOGRAPH(S) FOR THE DEVICE RELATED TO THE REPORTED EVENT RUPTURE WAS REQUESTED ON 09-JANUARY-2024. LOT NUMBER 2161962 CAN BE OBSERVED ON THE DEVICE. VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: ¿ RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. NO ADDITIONAL OBSERVATIONS. NO FURTHER ACTIONS ARE REQUIRED AS NO MANUFACTURING ISSUES ARE OBSERVED.

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO E.1. COUNTRY: "TREATING HEALTHCARE PROFESSIONAL IS IN GERMANY AND PATIENT IS LIVING IN GERMANY. IMPLANTING AND EXPLANTING SURGERY WAS PERFORMED IN CZECH REPUBLIC." CORRECTION TO G.3. AWARE DATE OF INITIAL MEDWATCH. AWARE DATE SHOULD HAVE BEEN LISTED AS 7-NOV-2023. CONTINUED H.10. RELATED REPORT NUMBERS: INFORMATION CONTAINED IN THIS REPORT WAS PREVIOUSLY SUBMITTED VIA EMDR MANUFACTURER REPORT NUMBER 9617229-2023-19675. ALL INFORMATION HAS BEEN CONSOLIDATED INTO THIS REPORT. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A2, A6, B3, B5, B6, E1, E2, E3, G2, H10, H11.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THIS RECORD RELATES TO THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ALLERGAN DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THIS RECORD RELATES TO THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ALLERGAN DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THIS RECORD RELATES TO THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ALLERGAN DEVICE.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE PAIN AND RUPTURE. PATIENT LATER REPORTED RIGHT SIDE IMPLANT WAS "DEFECTIVE AND HAD LEAKED IN THE CAPSULE", "STINGING", "PRESSURE HYPERSENSITIVITY OF THE NIPPLES", AND "FEAR EVERY DAY" THAT IMPLANT COULD LEAK AGAIN. HEALTHCARE PROFESSIONAL CONFIRMED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ALLERGAN DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490561 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2161962

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention