BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 3020593 · Received March 21, 2013

    Report

    Report Number
    2024601-2013-00246
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT ON: (B)(4) 2013. DEVICE LABELING FOR (B)(4) STUDY: (REVISION AUGMENTATION PATIENTS) MALPOSITION 6.1%. DEVICE LABELING ALSO NOTES: "THE SURGEON SHOULD OBSERVE CURRENT AND ACCEPTED TECHNIQUES TO MINIMIZE THE RISK OF ADVERSE, AND POTENTIALLY DISFIGURING, REACTIONS, BEARING IN MIND THE IMPORTANCE OF POCKET DISSECTION IN MINIMIZING IMPLANT ROTATION FOR THE SHAPED TRUFORM 3 (410) IMPLANT."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED RIGHT SIDE "SEVERE CAPSULE IN CAPSULE AND ROTATION." THIS REPORT IS FOR THE RIGHT SIDE DEVICE; NO ADVERSE EVENTS REPORTED FOR THE LEFT SIDE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118839 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT FTR ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention NO INFO