BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 17668216 · Received September 1, 2023

    Report

    Report Number
    9617229-2023-14277
    Event Type
    Injury
    Date Received
    September 1, 2023
    Report Date
    November 29, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191607544
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. DEVICE EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. NO FURTHER ACTIONS ARE REQUIRED SINCE NO ISSUE IN THE MANUFACTURING OF THE DEVICE IS OBSERVED.

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO D.4. DEVICE INFORMATION: SERIAL, LOT, AND CATALOG NUMBERS PROVIDED FOR BOTH SIDES, BUT INFORMATION IS NOT POPULATED AS THE AFFECTED SIDE OF THE RUPTURE IS UNKNOWN. LEFT SN: (B)(6); LEFT LOT: 2952383; LEFT CATALOG: N-TSF485. RIGHT SN: (B)(6); RIGHT LOT: 2952323; RIGHT CATALOG: N-TSF520. 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.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL LATER REPORTED "THE LEFT IS THE IMPLANT IN THE SYRINGE" REFERRING TO IMAGE OF RUPTURED IMPLANT. THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262258 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2952383 05060191607544

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention