BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 15214598 · Received August 11, 2022

    Report

    Report Number
    9617229-2022-13536
    Event Type
    Injury
    Date Received
    August 11, 2022
    Date of Event
    April 1, 2022
    Report Date
    November 28, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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-CONFORMANCE'S NOTED. 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: DEVICE RUPTURE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA.

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO FDA REPORT NUMBER: MW 5112025. THE EVENTS OF CAPSULAR CONTRACTURE AND SEROMA-LATE ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, B6, D6B, G2, H6.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED VIA REGULATORY AGENCY, "AN INTRACAPSULAR RUPTURE AND A BREAK IN THE SHELL SO THERE IS AN EXTRA CAPSULAR RUPTURE, AND FLUID INSIDE THE IMPLANT."

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED LEFT CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326360 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1410050

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention