BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 16086566 · Received January 3, 2023

    Report

    Report Number
    9617229-2022-23752
    Event Type
    Injury
    Date Received
    January 3, 2023
    Report Date
    March 9, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE REPORTED EVENTS OF "CAPSULAR CONTRACTURE, BAKER GRADE III" AND "SEROMA-LATE" ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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 AND SEROMA-LATE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ANXIETY-PRODUCT/PROCEDURE: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. CAPSULAR CONTRACTURE: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. SEROMA: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. INFLAMMATION/IRRITATION: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE ADDITIONAL OBSERVATIONS: CREASE FOLD OBSERVED IN THE DEVICE. WEAR ABRASION OBSERVED IN THE DEVICE. DEFORMATION OBSERVED IN THE DEVICE. RED PARTICLES OBSERVED IN THE DEVICE.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE "PREVENTATIVE REPLACEMENT." HEALTHCARE PROFESSIONAL LATER REPORTED "SEROMA" AND "CAPSULAR CONTRACTURE, BAKER GRADE III." THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE "PREVENTATIVE REPLACEMENT." HEALTHCARE PROFESSIONAL LATER REPORTED "SEROMA" AND "CAPSULAR CONTRACTURE, BAKER GRADE III." THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE "PREVENTATIVE REPLACEMENT." HEALTHCARE PROFESSIONAL LATER REPORTED "SEROMA" AND "CAPSULAR CONTRACTURE, BAKER GRADE III." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED INFLAMMATION/IRRITATION. THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE "PREVENTATIVE REPLACEMENT." HEALTHCARE PROFESSIONAL LATER REPORTED "SEROMA" AND "CAPSULAR CONTRACTURE, BAKER GRADE III." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED INFLAMMATION/IRRITATION. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523867 STYLE 115 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2235205

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention