BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 8704390 · Received June 17, 2019

    Report

    Report Number
    9617229-2019-06467
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    July 15, 2018
    Report Date
    October 1, 2020
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL ANALYSIS OF THE IDENTIFIED PHOTOS: CREASE FOLD, WEAR ABRASION, YELLOW PARTICLES INNER THE SHELL, APPARENTLY THE UNIT HAS AN OPENING BECAUSE THERE IS NO FLUID INSIDE THE SHELL BUT CANNOT BE CONFIRMED DUE TO PHOTO QUALITY AND LABELED AS RIGHT SIDE. 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 LATER REPORTED "PARTICLES IN VALVE." DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE REASON FOR REOPERATION IS DEFLATION. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    PATIENT REPORTED A RIGHT SIDE HAS A "LEAK" BECAUSE IT IS GETTING "SMALLER" THAN THE LEFT. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498317 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2295230

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention