BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATRELLE STYLE 110 REF #110-300

    MDR report key: 2973798 · Received February 13, 2013

    Report

    Report Number
    MW5029018
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    November 20, 2012
    Report Date
    February 13, 2013
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ALCL RIGHT BREAST PRESENTED WITH PERSISTENT SEROMAS THAT REQUIRED MULTIPLE ASPIRATIONS TEXTURED IMPLANT PLACED IN THE SUBFASCIAL PECTORAL PLANE. SALT BASED TEXTURE. FULL CAPSULECTOMY WITH REMOVAL OF IMPLANT DONE ON (B)(6) 2012 INTERCONSULTATION WITH MED / ONCOLOGY RECOMMENDED CHEMOTHERAPY THAT CURRENT IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64086 NATRELLE STYLE 110 REF #110-300 NONE FWM ALLERGAN NATRELLE STYLE 110 110-300

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other| R