BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 19082697 · Received April 10, 2024

    Report

    Report Number
    9617229-2024-06224
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    February 15, 2024
    Report Date
    July 29, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. PHONE NUMBER CONTINUED: (B)(6). E1. FAX NUMBER CONTINUED: (B)(6). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE REPORTED EVENTS 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 IV, SEROMA, RASH, PAIN VISUAL ANALYSIS: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: DEVICE PATCH WITH LOT NUMBER 2914502 AND CATALOG NUMBER 115-290. PAIN-BREAST: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. NO ADDITIONAL OBSERVATIONS ARE PERFORMED. NO FURTHER ACTIONS ARE REQUIRED SINCE NO ISSUE IN THE MANUFACTURING OF THE DEVICE IS OBSERVED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: DEVICE PATCH WITH LOT NUMBER 2914502 AND CATALOG NUMBER 115-290. PAIN-BREAST: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. NO ADDITIONAL OBSERVATIONS ARE PERFORMED. NO FURTHER ACTIONS ARE REQUIRED SINCE NO ISSUE IN THE MANUFACTURING OF THE DEVICE IS OBSERVED. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9; H3; H6;

    Description of Event or Problem · 0

    .HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE PAIN. HEALTHCARE PROFESSIONAL LATER REPORTED "RASH, SERIOUS FLUID, CAPSULAR CONTRACTURE BAKER GRADE IV," BIOFILM REMOVAL AND CHRONIC INFLAMMATION. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE PAIN. HEALTHCARE PROFESSIONAL LATER REPORTED "RASH, SERIOUS FLUID, CAPSULAR CONTRACTURE BAKER GRADE IV," BIOFILM REMOVAL AND CHRONIC INFLAMMATION. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231875 STYLE 115 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2914502

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention