BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 8782006 · Received July 11, 2019

    Report

    Report Number
    9617229-2019-08259
    Event Type
    Injury
    Date Received
    July 11, 2019
    Date of Event
    February 15, 2017
    Report Date
    June 2, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D.10, G.1, H.3, H.6 DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE, DEVICE MIGRATION, CREASE/FOLDING OF IMPLANT AND INFLAMMATION/IRRITATION, WAS RECEIVED ON MAR 17, 2020 WITH LOT NUMBER 2944857. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED, THE WEIGHT THE DEVICE WITHIN SPECIFICATION, CREASE FLAT, DEFORMATION AND CLOUDY COLOR IN THE GEL. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: NO OTHER OBSERVATION OBSERVED. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: CREASES ARE OBSERVED BUT HAVE NOT RELATIONSHIP WITH MANUFACTURING.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE IV", "FOLDS", "LYMPH NODES", "IMPLANT ROTATION", "PAIN", AND "SIGNS OF CAPSULITIS". TREATMENT WITH SINGULAIR WAS GIVEN. THE DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    INFORMATION CONTAINED IN THIS RECORD WAS PREVIOUSLY SUBMITTED THRU PSR ON 22/JAN/2019 AND 22/APR/2019. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCE'S NOTED. REASON FOR REOPERATION IS CAPSULAR CONTRACTURE BAKER GRADE IV. 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. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE IV", "FOLDS", "LYMPH NODES", "IMPLANT ROTATION", "PAIN", AND "SIGNS OF CAPSULITIS". TREATMENT WITH SINGULAIR WAS GIVEN. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575376 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2944857

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention