BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 12153530 · Received July 12, 2021

    Report

    Report Number
    9617229-2021-47506
    Event Type
    Injury
    Date Received
    July 12, 2021
    Date of Event
    May 15, 2021
    Report Date
    August 25, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628033146
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: "THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE WAS RECEIVED ON JUNE 28, 2021 WITH LOT NUMBER 3000947. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: OPENING CURVED ON POSTERIOR AND WEIGHT TO THE SPEC. A VISUAL AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: STRIATED OPENING ON POSTERIOR, CREASES FOLD AND NON-PENETRATING NICKS. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A STRIATED OPENING ON POSTERIOR ASSESSED AS SURGICAL DAMAGE CONSIST IN THE USE OF SOME SURGICAL TOOL."

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES 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.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050304 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) SSF-365 3000947 10888628033146

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention