BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 8741186 · Received June 27, 2019

    Report

    Report Number
    9617229-2017-03038
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    March 15, 2017
    Report Date
    June 27, 2019
    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 · 1

    INFORMATION CONTAINED IN THIS RECORD WAS PREVIOUSLY SUBMITTED THRU PSR ON 23/OCT/2017, 22/JAN/2018, 15/OCT/2018, AND 22/JAN/2019. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: WEIGHT TO THE SPECTRUM, CREASE FOLDS AND DEFORMATION. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: NO ISSUES WERE FOUND RELATED WITH THE MANUFACTURING PROCESS. REASON FOR REOPERATION IS CAPSULAR CONTRACTURE BAKER GRADE III AND SEROMA-LATE. THE EVENTS OF CAPSULAR CONTRACTURE AND SEROMA-LATE ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III ¿PAIN¿, ¿BREAST MODIFICATION (DOWN)¿ "RADIAL FOLDS", AND ¿SMALL QUANTITY OF LIQUID AROUND DEVICE¿. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534108 INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2525015

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention