BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 8784930 · Received July 12, 2019

    Report

    Report Number
    9617229-2019-08587
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    May 13, 2019
    Report Date
    July 12, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE FURTHER INVESTIGATION HAS BEEN INITIATED. IF ANY NEW, CHANGED, OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. 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. THE REASON FOR REOPERATION IS RUPTURE. FURTHER INFORMATION FROM THE REPORTER REGARDING THE EVENTS, PRODUCT, AND PATIENT DETAILS HAVE BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THESE ARE KNOWN POTENTIAL ADVERSE EVENTS ADDRESSED IN THE PRODUCT LABELING.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577321 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2796945

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention