BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 18065950 · Received November 3, 2023

    Report

    Report Number
    9617229-2023-18063
    Event Type
    Injury
    Date Received
    November 3, 2023
    Report Date
    November 28, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191607308
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENTS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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: CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, SEROMA LATE, RUPTURE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED AGAINST THE RIGHT SIDE "HETEROGENEOUS RIGHT BREAST PROSTHESIS WITH THE PRESENCE OF ADJACENT FLUID, ESPECIALLY IN THE QIM" AND "SUSPICIOUS SIGNS OF EXTRA-CAPSULAR RUPTURE OF THE RIGHT BREAST PROSTHESIS, WITH MRI RECOMMENDED". DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LATER REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952843 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2973866 05060191607308

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention