BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 8619843 · Received May 17, 2019

    Report

    Report Number
    9617229-2019-03261
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    April 17, 2019
    Report Date
    September 4, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: WEAR ABRASION, CREASE FOLD, OPENING ON POSTERIOR BROWN AND YELLOW PARTICLES DEVICE INNER SURFACE AND RED PARTICLES IN FILL CHANNEL. LEAK TEST AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: OPENING CREASE SHARP, OPENING CREASE SMOOTH AND OBSERVED VOID >1 MM IN NON-TEXTURED, VALVE-TO SHELL-BOND AREA. THE FILL TEST INSPECTION WAS PERFORMED, THE RESULT IS NO BLOCKAGE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: AN OPENING CREASE SHARP ON ANTERIOR DUE TO FOLD FLAW OPENING, AND A SMOOTH CREASE OPENING ON POSTERIOR DUE TO FOLD FLAW OPENING.

    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. THE REASON FOR REOPERATION IS DEFLATION. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. THE DEVICE WAS EXPLANTED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413999 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1411348

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention