BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 12053313 · Received June 23, 2021

    Report

    Report Number
    9617229-2021-07826
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    May 25, 2021
    Report Date
    July 22, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: OPENING, BROWN PARTICLES IN THE FILL CHANNEL CREASE FLAT. LEAK TEST WAS PERFORMED AND FOUND OPENING ON ANTERIOR. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFY SHARP IN THE VALVE BOND EDGE. THE FILL TEST INSPECTION WAS PERFORMED, THE RESULT IS NO BLOCKAGE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A SHARP OPENING ON VALVE BOND EDGE ASSESSED AS AN UNIDENTIFIED (TEAR) 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. 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 PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946575 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1404579

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention