BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 18667866 · Received February 8, 2024

    Report

    Report Number
    9617229-2024-02210
    Event Type
    Injury
    Date Received
    February 8, 2024
    Date of Event
    November 3, 2023
    Report Date
    April 22, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT RUPTURE, WRINKLING, MALPOSITION, INFLAMMATION/IRRITATION, CREASE FOLDING OF IMPLANT AND CAPSULAR CONTRACTURE WAS RECEIVED ON MARCH 05, 2024, WITH LOT NUMBER 2040533. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE: OBSERVED OPENING ON POSTERIOR SIDE ASSESSED AS UNIDENTIFIED (TEAR) OPENING. SHELL THICKNESS WITHIN SPECIFICATION. WRINKLING: OBSERVED WRINKLING ON THE DEVICE. MALPOSITION: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. INFLAMMATION/IRRITATION: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. CREASE FOLDING OF IMPLANT: OBSERVED CREASES ON THE DEVICE. CAPSULAR CONTRACTURE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ADDITIONAL OBSERVATIONS: NO OTHER OBSERVATIONS OBSERVED. NO FURTHER ACTIONS ARE REQUIRED AS THE DEVICE WAS IMPLANTED.

    Additional Manufacturer Narrative · 0

    CONTINUED: E1 PHONE NO.: (B)(6). FAX NO.: (B)(6). 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. REASON FOR REOPERATION: RUPTURE AND CAPSULAR CONTRACTURE, BAKER GRADE III.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED IMPLANT RUPTURE, SILICON PERSPIRATION, FOLDS, WAVES, ROTATION, INFLAMMATION AND CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE LEFT SIDE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED IMPLANT RUPTURE, SILICON PERSPIRATION, FOLDS, WAVES, ROTATION, INFLAMMATION AND CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE LEFT SIDE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED IMPLANT RUPTURE, SILICON PERSPIRATION, FOLDS, WAVES, ROTATION, INFLAMMATION AND CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278617 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2040533

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention