BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 12366548 · Received August 25, 2021

    Report

    Report Number
    9617229-2021-17098
    Event Type
    Injury
    Date Received
    August 25, 2021
    Date of Event
    April 15, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF PATIENT-DEVICE INCOMPATIBILITY, HEMATOMA, AND CAPSULAR CONTRACTURE, WAS RECEIVED ON MAY 10, 2021 WITH LOT NUMBER 3131238. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED, THE WEIGHT THE DEVICE WITHIN SPECIFICATION AND FOLD CREASES. AFTER AUTOCLAVE CYCLE WAS OBSERVED: CLOUDY COLOR IN THE GEL. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: - NO ISSUES FOUND RELATED WITH THE MANUFACTURING PROCESS. 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: HEMATOMA AND CAPSULAR CONTRACTURE, BAKER GRADE IV.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE HEMATOMA AND CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261699 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3131238

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention