BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 11127415 · Received January 6, 2021

    Report

    Report Number
    9617229-2020-22181
    Event Type
    Injury
    Date Received
    January 6, 2021
    Report Date
    February 4, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628008335
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS: THE DEVICE RELATED TO THE REPORTED EVENT THE DEVICE ANXIETY-PRODUCT/PROCEDURE, RUPTURE AND CAPSULAR CONTRACTURE WAS RECEIVED JANUARY 18, 2021 WITH LOT NUMBER 2912045. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: WEIGHT WITHIN SPECIFICATION, CREASES FLAT, BLACK MOLD LIKE AND YELLOW BIOLOGICAL. GEL WAS OBSERVED TO BE CLOUDY AFTER AUTOCLAVE CYCLE. THE UNIT IS NOT RUPTURED. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: NO ISSUES FOUND RELATED WITH THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE II AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    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, CAPSULAR CONTRACTURE BAKER GRADE II AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE II AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23181 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) TRF-415 2912045 10888628008335

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention