BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 110 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 10165244 · Received June 17, 2020

    Report

    Report Number
    9617229-2020-09045
    Event Type
    Injury
    Date Received
    June 17, 2020
    Date of Event
    March 15, 2020
    Report Date
    June 17, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED A BROKEN SHELL. DEVICE PATCH WITH LOT NUMBER: 2270974 AND CATALOG NUMBER: 110-420. DEVICE ANALYSIS PERFORMED THROUGH PHOTOGRAPHS, DUE TO THE IMPOSSIBILITY TO PERFORM MICROSCOPIC ANALYSIS IT IS NOT POSSIBLE TO DETERMINE THE MOST LIKELY FAILURE MODE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE AND IMPLANT EXCHANGE DUE TO PATIENT'S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES 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: RUPTURE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE AND IMPLANT EXCHANGE DUE TO PATIENT'S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629595 STYLE 110 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2270974

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention