BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 20163616 · Received September 6, 2024

    Report

    Report Number
    9617229-2024-20237
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 27, 2024
    Report Date
    October 2, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. PHOTO ANALYSIS: DEVICE PHOTOGRAPH(S) FOR THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE REQUESTED ON SEP 09, 2024. WITH LOT NUMBER 2202901 AND CATALOG 115-272. ¿ RUPTURE: OBSERVED, OPENING ON THE DEVICE BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. NO FURTHER ACTIONS ARE REQUIRED SINCE NO ISSUE IN THE MANUFACTURING OF THE DEVICE IS OBSERVED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE WAS RECEIVED ON OCTOBER 17, 2024 WITH LOT NUMBER 2202901. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ¿ RUPTURE: OBSERVED BROKEN DEVICE ASSESSED AS UNIDENTIFIED (TEAR) OPENING (SHELL THICKNESS WITHIN SPECIFICATION) AND MISSING SHELL ASSESSED AS INCONCLUSIVE. AS PER THE INVESTIGATION PROCEDURE CREASES WERE COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    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: RUPTURE.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE "RUPTURE" CONFIRMED VIA ULTRASOUND. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT SIDE "RUPTURE" CONFIRMED VIA ULTRASOUND. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    PATIENT REPORTED, RIGHT SIDE "RUPTURE". CONFIRMED VIA ULTRASOUND. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066580 STYLE 115 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2202901

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention