BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22410671 · Received July 7, 2025

    Report

    Report Number
    9617229-2025-11191
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    May 2, 2025
    Report Date
    September 2, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628007116
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: G.3. AWARE DATE IN SUPPLEMENTAL MEDWATCH 1 SHOULD HAVE BEEN LISTED AS 05AUG2025.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF "SEROMA-LATE" 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: RUPTURE AND SEROMA-LATE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D6B D9 H3 H6. LABORATORY ANALYSIS SUMMARY: THE DEVICE RELATED TO THE REPORTED EVENT OF SEROMA-LATE RUPTURE WAS RECEIVED ON JUL 15, 2025, WITH LOT NUMBER 3033051. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: RUPTURE: OBSERVED BROKEN DEVICE ASSESSED AS FOLD FLAW OPENING AND MISSING ASSESSED AS INCONCLUSIVE. SEROMA-LATE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. AS PER THE INVESTIGATION PROCEDURE, CREASE AND NON-PENETRATING NICK WERE COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE AND EXTRACAPSULAR FLUID". DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE AND EXTRACAPSULAR FLUID". DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE AND EXTRACAPSULAR FLUID". DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951489 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3033051 10888628007116

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention