BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 14091935 · Received April 13, 2022

    Report

    Report Number
    9617229-2022-05260
    Event Type
    Injury
    Date Received
    April 13, 2022
    Report Date
    November 2, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628007031
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF "CAPSULAR CONTRACTURE, BAKER GRADE III" 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: CAPSULAR CONTRACTURE, BAKER GRADE III.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE WAS RECEIVED ON SEPTEMBER 21, 2022 WITH LOT NUMBER: 3061982. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: CAPSULAR CONTRACTURE: UNABLE TO OBSERVE SINCE IT IS A MEDICAL EVENT AND IS NOT RELATED TO THE DEVICE. ADDITIONAL OBSERVATIONS: CREASE FOLD OBSERVED ON THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED AS THE DEVICE WAS IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810673 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) SRM-210 3061982 10888628007031

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention