BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 10385350 · Received August 10, 2020

    Report

    Report Number
    9617229-2020-12178
    Event Type
    Injury
    Date Received
    August 10, 2020
    Date of Event
    June 13, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628033085
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF "CAPSULAR CONTRACTURE" 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. DEVICE PHOTO EVALUATION: VISUAL ANALYSIS OF THE IDENTIFIED PHOTOS: RED PARTICLES IN THE SHELL, CREASE FOLD, DEFORMATION, DEVICE PATCH WITH LOT NUMBER 3192811 AND LABELED AS LEFT SIDE. DEVICE ANALYSIS PERFORMED THROUGH PHOTOGRAPHS, DUE TO THE IMPOSSIBILITY TO PERFORM MICROSCOPIC ANALYSIS IT IS NOT POSSIBLE TO DETERMINE THE MOST LIKELY FAILURE MODE REASON FOR REOPERATION: CAPSULAR CONTRACTURE BAKER GRADE IV.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847886 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) SSF-240 3192811 10888628033085

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention