BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 8645425 · Received May 28, 2019

    Report

    Report Number
    9617229-2019-03786
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    May 1, 2019
    Report Date
    July 17, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: CREASES FOLD, WEAR ABRASION AND DELAMINATION VALVE LEAK TEST AND MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: DELAMINATION PARTIAL OF THE VALVE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A DELAMINATION PARTIAL OF THE VALVE (ADHESIVE FAILURE).

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. THE DEVICE WAS EXPLANTED.

    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-CONFORMANCE NOTED. REASON FOR REOPERATION DUE TO 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 RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441049 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 620484

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention