BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 21971727 · Received May 6, 2025

    Report

    Report Number
    9617229-2025-07367
    Event Type
    Injury
    Date Received
    May 6, 2025
    Date of Event
    May 1, 2024
    Report Date
    May 6, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    -
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED E1 (PHONE NO.): (B)(6). CLARIFICATION G4 (PMA): THE DEVICE IS PMA APPROVED. PMA/ 510(K)# IS P020056. 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.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED FOR RIGHT SIDE "QUALITY FAILURE - RIGHT PROSTHETIC RUPTURE", "RIGHT IMPLANT WITH FOLDED MEMBRANE AND INCREASED PERMEABILITY DUE TO INTRACAPSULAR RUPTURE" AND "IT HAS PERIPHERAL FOLDS", "INFLAMMATION AND PAIN." THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2102799 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3047531

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention