BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 12506246 · Received September 21, 2021

    Report

    Report Number
    9617229-2021-50473
    Event Type
    Injury
    Date Received
    September 21, 2021
    Date of Event
    August 10, 2021
    Report Date
    October 25, 2021
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: CREASE FOLD, WEAR ABRASION, YELLOW PARTICLES INNER THE SHELL AND OPENING ON VALVE. MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: CRACK OPENING ON VALVE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A CRACKED VALVE SEAT DIAPHRAGM VALVE. TREND REVIEW SUMMARY: REVIEW OF ALL COMPLAINTS OF A050401 - FLUID LEAK FOR THE PERIOD OF AUG 2019 THROUGH JUL 2021 RELATED TO DATE OPENED INDICATES THAT NINE POINTS ARE 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 ¿P-CHART OF A050401 FLUID LEAK-SALINE BREAST IMPLANTS AND ADDITIONAL ANALYSIS¿ 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 A LEFT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCE 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".

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405579 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM 616863

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention