BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 12442350 · Received September 8, 2021

    Report

    Report Number
    9617229-2021-49803
    Event Type
    Injury
    Date Received
    September 8, 2021
    Date of Event
    July 15, 2021
    Report Date
    February 1, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED; FOLD CREASES, CURVED OPENING, YELLOW PARTICLES ON SHELL. THE LEAK TEST AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: A CURVED STRIATED OPENING ON POSTERIOR AND SHARP OPENING ON POSTERIOR (NO SHELL THICKNESS DUE TO OPENING SIZE). THE FILL TEST INSPECTION WAS PERFORMED, THE RESULT IS NO BLOCKAGE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A STRIATED OPENING ASSESSED AS SURGICAL DAMAGE. A SHARP OPENING ASSESSED AS UNIDENTIFIED(TEAR) OPENING 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 LEFT SIDE "DEFLATION". DEVICE WAS 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: DEFLATION.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "DEFLATION". DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340158 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 555257

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention