BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 8731315 · Received June 25, 2019

    Report

    Report Number
    9617229-2019-06840
    Event Type
    Injury
    Date Received
    June 25, 2019
    Date of Event
    May 27, 2019
    Report Date
    April 9, 2020
    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: WEAR ABRASION, WHITE PARTICLES AND OPENING CURVED ON ANTERIOR LEAK TEST AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: SHARP OPENING ON ANTERIOR, OBSERVED VOID >1 MM IN NON-TEXTURED, VALVE-TO SHELL-BOND AREA AND CREASES FLAT. THE FILL TEST INSPECTION WAS PERFORMED, THE RESULT IS NO BLOCKAGE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A SHARP OPENING ON ANTERIOR (VALVE BOND EDGE) ASSESSED AS AN UNIDENTIFIED (TEAR) OPENING.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED "FLAT" IMPLANT ON RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN INITIATED. IF ANY NEW, CHANGED, OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THE REASON FOR REOPERATION WAS DEFLATION. FURTHER INFORMATION FROM THE REPORTER REGARDING THE EVENTS, PRODUCT, AND PATIENT DETAILS HAVE 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

    PHYSICIAN REPORTED "FLAT" IMPLANT ON RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524821 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1809194

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention