BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 15366729 · Received September 6, 2022

    Report

    Report Number
    9617229-2022-15463
    Event Type
    Injury
    Date Received
    September 6, 2022
    Report Date
    December 13, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191601351
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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, GRADE 3¿ 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: "PREVENTATIVE REPLACEMENT" AND ¿CAPSULAR CONTRACTURE, GRADE 3¿.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF ANXIETY-PRODUCT/PROCEDURE AND CAPSULAR CONTRACTURE WAS RECEIVED ON (B)(6), 2022, WITH LOT NUMBER 2912367. 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. ADDITIONAL OBSERVATIONS: DEFORMATION OBSERVED IN THE DEVICE. WEAR ABRASION OBSERVED IN THE SURFACE OF THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED AS THE DEVICE WAS IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "PREVENTATIVE REPLACEMENT" AND ¿CAPSULAR CONTRACTURE, GRADE 3¿ AGAINST LEFT SIDE DEVICE. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "PREVENTATIVE REPLACEMENT" AND ¿CAPSULAR CONTRACTURE, GRADE 3¿ AGAINST LEFT SIDE DEVICE. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "PREVENTATIVE REPLACEMENT" AND ¿CAPSULAR CONTRACTURE, GRADE 3¿ AGAINST LEFT SIDE DEVICE. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2458944 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2912367 05060191601351

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention