BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 15113727 · Received July 27, 2022

    Report

    Report Number
    9617229-2022-12436
    Event Type
    Injury
    Date Received
    July 27, 2022
    Date of Event
    June 9, 2022
    Report Date
    July 27, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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-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: DEFLATION. DHR TREND SUMMARY REVIEW OF ALL COMPLAINTS OF A050401 - FLUID LEAK FOR THE PERIOD OF JUN 2020 THROUGH MAY 2022 RELATED TO DATE OPENED INDICATES THAT 1 POINT IS ABOVE THE UPPER CONTROL LIMIT. ACCORDING TO THE SEVERITY, AN ADDITIONAL ANALYSIS WAS PERFORMED TO REVIEW THE INVOLVED COMPLAINTS WITH MANUFACTURING DATE OVER THE PAST 24 MONTHS. SEE ¿I CHART OF A050401 FLUID LEAK FOR SALINE BREAST IMPLANTS¿ ATTACHED. NO PATTERNS WERE FOUND; THEREFORE, NO ADDITIONAL ACTIONS ARE DEEMED REQUIRED. THE TREND OF A050401 - FLUID LEAK COMPLAINTS WILL CONTINUE TO BE MONITORED AND CORRECTIVE ACTIONS WILL BE TAKEN IN THE FUTURE IF DEEMED APPROPRIATE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703991 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1421051

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention