BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 8533314 · Received April 19, 2019

    Report

    Report Number
    9617229-2019-02542
    Event Type
    Injury
    Date Received
    April 19, 2019
    Date of Event
    March 15, 2019
    Report Date
    July 24, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    UDI-DI
    10888628000469
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ANALYSIS OF THE RETURNED DEVICE IDENTIFIED CREASES FOLD, GREEN PARTICLES AND OPENING CURVED ON ANTERIOR. LEAK TEST AND MICROSCOPIC ANALYSIS WERE PERFORMED WHICH IDENTIFIED A STRIATED OPENING ON ANTERIOR, A SHARP OPENING ON ANTERIOR, OBSERVED VOID >1 MM IN NON-TEXTURED, VALVE-TO SHELL-BOND AREA, NON-PENETRATING NICKS AND WEAR ABRASION. THE FILL TEST INSPECTION WAS PERFORMED; THE RESULT IS NO BLOCKAGE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A STRIATED OPENING ON ANTERIOR DUE TO SURGICAL DAMAGE CONSISTENT IN THE USE OF SOME SURGICAL TOOL AND A SHARP OPENING ON ANTERIOR (VALVE BOND EDGE) DUE TO AN UNIDENTIFIED (TEAR) OPENING. THE REASON FOR REOPERATION IS DEFLATION.

    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. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326583 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 3022478 10888628000469

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention