BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 8622560 · Received May 19, 2019

    Report

    Report Number
    9617229-2019-03473
    Event Type
    Injury
    Date Received
    May 19, 2019
    Report Date
    July 24, 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 · 1

    THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE REASON FOR REOPERATION IS RUPTURE AND CAPSULAR CONTRACTURE, BAKER GRADE IV. 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 LEFT SIDE DEFLATION AND CAPSULAR CONTRACTURE, BAKER GRADE IV. ADDITIONAL REPORT OF "425 FILLED TO 480 LEFT". DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415953 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention