BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 12129528 · Received July 7, 2021

    Report

    Report Number
    9617229-2021-47084
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    June 15, 2021
    Report Date
    October 6, 2021
    Product Code
    FWM
    UDI-DI
    10888628000308
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF DEFLATION WAS RECEIVED ON SEPTEMBER 28, 2021 WITH LOT NUMBER 3123704. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: FOLD CREASES, YELLOW PARTICLES IN DEVICE INNER SURFACE AND ONE LINEAR OPENING. A MICROSCOPIC ANALYSIS AND LEAK TEST WERE PERFORMED WHICH IDENTIFIED ONE OPENING CREASE SMOOTH AND WEAR ABRASION. FILL INSPECTION WAS PERFORMED AND IDENTIFIED NO BLOCKAGE IN THE VALVE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: ONE OPENING CREASE SMOOTH IN THE SIDE RADIUS ASSESSED AS FOLD FLAW OPENING.

    Description of Event or Problem · 0

    DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: DEFLATION.

    Description of Event or Problem · 1

    HEALTHCARE PROVIDER CALLED TO REPORT A RIGHT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026853 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM 68-600 3123704 10888628000308

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention