BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 3030985 · Received November 29, 2012

    Report

    Report Number
    2024601-2012-01283
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    August 5, 2008
    Report Date
    August 5, 2008
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SUBMITTED ON: (B)(4) 2012. DEVICE LABELING REVIEWED: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL, FOR PTS IN THE (B)(4) STUDY, IN THE LABELING FOR SILICONE IMPLANTS.

    Description of Event or Problem · 1

    LEFT SIDE: REPORTED AS ANAPLASTIC LARGE CELL LYMPHOMA, CONTRACTURE, AND ASSOCIATED ASYMMETRY FROM RESEARCH ARTICLE PUBLISHED 2008 AMERICAN JOURNAL OF SURGICAL PATHOLOGY, WONG ET AL. 'ANAPLASTIC LARGE CELL LYMPHOMA ASSOCIATED WITH A BREAST IMPLANT CAPSULE: A CASE REPORT AND REVIEW OF THE LITERATURE.' F/U FINDINGS: DOCTOR STATES IS ALLERGAN DEVICE BUT IS UNABLE TO EXONERATE DEVICE AS INSUFFICIENT STUDY EVIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK MAMMARY IMPLANT FWM ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention NO INFO