BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 8701881 · Received June 14, 2019

    Report

    Report Number
    9617229-2019-06255
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    April 23, 2019
    Report Date
    September 17, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    UDI-DI
    10888628000230
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ANALYSIS OF THE RETURNED DEVICE IDENTIFIED CREASES FOLD, WEAR ABRASION, AND AN OPENING(LINEAR) ON POSTERIOR AND RADIUS. LEAK TEST AND MICROSCOPIC ANALYSIS WERE PERFORMED WHICH IDENTIFIED A STRIATED OPENING ON RADIUS, CREASE(SMOOTH) OPENING ON POSTERIOR AND OBSERVED VOID >1 MM IN NON-TEXTURED, VALVE-TO SHELL-BOND AREA. THE FILL TEST INSPECTION WAS PERFORMED WITH THE RESULT OF NO BLOCKAGE. BASED ON THE DEVICE ANALYSIS, THE FINAL ASSESSMENT IS A STRIATED OPENING ON RADIUS DUE TO SURGICAL DAMAGE CONSIST IN THE USE OF A SURGICAL TOOL, AND AN OPENING CREASE(SMOOTH) 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-CONFORMANCE'S NOTED. THE REASON FOR REOPERATION IS 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

    HEALTH PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE WAS EXPLANTED.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493440 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2911338 10888628000230

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention