BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 8708290 · Received June 18, 2019

    Report

    Report Number
    9617229-2019-06428
    Event Type
    Injury
    Date Received
    June 18, 2019
    Date of Event
    May 21, 2019
    Report Date
    July 25, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    UDI-DI
    10888628000285
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    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 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

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503247 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2702898 10888628000285

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention