BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 14478899 · Received May 23, 2022

    Report

    Report Number
    9617229-2022-09166
    Event Type
    Injury
    Date Received
    May 23, 2022
    Date of Event
    March 29, 2022
    Report Date
    July 13, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 INVESTIGATION: NO PATTERNS WERE FOUND; THEREFORE, NO ADDITIONAL ACTIONS ARE DEEMED REQUIRED. THE TREND OF (B)(4) - FLUID LEAK COMPLAINTS WILL CONTINUE TO BE MONITORED AND CORRECTIVE ACTIONS WILL BE TAKEN IN THE FUTURE IF DEEMED APPROPRIATE. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D.9, G.1, H.3, H.6. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF DEFLATION RECEIVED ON (B)(6) 2022, WITH LOT NUMBER 1121951. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: CREASES FOLD AND OPENING CURVED ON POSTERIOR. LEAK TEST AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: OPENING CREASE SMOOTH ON POSTERIOR, WEAR ABRASION, BROWN PARTICLES IN THE FILL CHANNEL AND YELLOW BIOLOGICAL TISSUE INNER DEVICE. THE FILL TEST INSPECTION WAS PERFORMED, THE RESULT IS NO BLOCKAGE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: AN OPENING CREASE SMOOTH ON POSTERIOR ASSESSED AS FOLD FLAW OPENING.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AGAINST LEFT DEVICE. THE DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AGAINST LEFT DEVICE. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487776 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1121951

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention