BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 8688462 · Received June 11, 2019

    Report

    Report Number
    9617229-2019-05857
    Event Type
    Injury
    Date Received
    June 11, 2019
    Date of Event
    April 10, 2019
    Report Date
    July 15, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ANALYSIS OF THE RETURNED DEVICE IDENTIFIED CREASES(FOLD), WEAR ABRASION, YELLOW PARTICLES, AND AN OPENING ON POSTERIOR. LEAK TEST AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED OPENING CREASES(SHARP), STRESS MARKS AND DELAMINATION OF VALVE (<75% PARTIAL SEPARATION). 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 AN OPENING CREASE(SHARP) ON ANTERIOR DUE TO FOLD(FLAW) OPENING, AND A DELAMINATION(PARTIAL) OF THE VALVE (ADHESIVE FAILURE).

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE WAS EXPLANTED.

    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

    HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483403 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2107975

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention