BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 14273171 · Received May 4, 2022

    Report

    Report Number
    9617229-2022-06838
    Event Type
    Injury
    Date Received
    May 4, 2022
    Report Date
    August 25, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628007185
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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-CONFORMANCE NOTED. 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: CAPSULAR CONTRACTURE BAKER GRADE III.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE WAS RECEIVED ON JUL 27, 2023, WITH LOT NUMBER 3113624. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ¿ CAPSULAR CONTRACTURE: UNABLE TO OBSERVE AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. ADDITIONAL OBSERVATIONS: ¿ OBSERVED OPENING ON POSTERIOR SIDE ASSESSED AS SURGICAL DAMAGE. ¿ OBSERVED CREASES 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 REMAINS IMPLANTED.

    Description of Event or Problem · 0

    DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III." THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244587 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) SRM-600 3113624 10888628007185

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention