BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 8672638 · Received June 5, 2019

    Report

    Report Number
    9617229-2019-05228
    Event Type
    Injury
    Date Received
    June 5, 2019
    Date of Event
    May 9, 2019
    Report Date
    July 30, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A FOLD CREASE, WEAR ABRASION, WHITE PARTICLES IN FILL CHANNEL, AND AN OPENING ON THE ANTERIOR AND POSTERIOR SIDE. A LEAK TEST AND MICROSCOPIC ANALYSIS WERE PERFORMED WHICH IDENTIFIED: A STRIATED OPENING, A SHARP OPENING AND A >1 MM VOID IN NON-TEXTURED, VALVE-TO SHELL-BOND AREA. THE FILL TEST INSPECTION WAS PERFORMED AND THE RESULT WAS NO BLOCKAGE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A SHARP OPENING ON THE ANTERIOR SIDE DUE TO AN UNIDENTIFIED (TEAR) OPENING AND A STRIATED OPENING DUE TO SURGICAL DAMAGE CONSISTENT WITH THE USE OF SOME SURGICAL TOOL.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE REASON FOR REOPERATION WAS DEFLATION. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465150 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1785647

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention