BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 17719153 · Received September 11, 2023

    Report

    Report Number
    9617229-2023-31061
    Event Type
    Injury
    Date Received
    September 11, 2023
    Date of Event
    August 7, 2023
    Report Date
    November 14, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE WAS RECEIVED ON 29-NOV 2023, WITH LOT NUMBER: 3182109. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE : NO OBSERVED. ADDITIONAL OBSERVATIONS: DEFORMATION OBSERVED ON THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED AS NO ISSUES WITH THE MANUFACTURING PROCESS ARE OBSERVED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. 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 RIGHT SIDE "RUPTURE OF IMPLANT." DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE OF IMPLANT." DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150247 INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3182109

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Female Required Intervention