BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 11170346 · Received January 14, 2021

    Report

    Report Number
    9617229-2020-22696
    Event Type
    Injury
    Date Received
    January 14, 2021
    Date of Event
    September 15, 2018
    Report Date
    January 14, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: VISUAL ANALYSIS OF THE PHOTOS IDENTIFIED RED PARTICLE MATERIAL ON THE SHELL; WHITE, RED ENCAPSULATION, DEFORMATION AND CREASES. DEVICE PATCH WITH LOT NUMBER 2884755. DEVICE ANALYSIS PERFORMED THROUGH PHOTOGRAPHS, DUE TO THE IMPOSSIBILITY TO PERFORM MICROSCOPIC ANALYSIS AS IT WAS NOT POSSIBLE TO DETERMINE THE MOST LIKELY FAILURE MODE. THE EVENT OF CAPSULAR CONTRACTURE BAKER GRADE III 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: CAPSULAR CONTRACTURE BAKER GRADE III.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE 3. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68861 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2884755

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention