BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SALINE IMPLANT

    MDR report key: 3030982 · Received November 20, 2012

    Report

    Report Number
    2024601-2012-01269
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    January 29, 2010
    Report Date
    January 29, 2010
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MED WATCH SUBMITTED: (B)(4) 2012. THIS EVENT WAS SENT INITIALLY VIA (B)(6) 2009; Q1 (B)(6) 2010; Q2 (B)(6) 2010 AND Q4 (B)(6) 2011. DEVICE LABELLING ADDRESSES THE EVENT OF SEROMA AS: FOR PRIMARY AUGMENTATION PTS, SEROMA RATE = (B)(4). PRIMARY RECONSTRUCTION PTS = (B)(4) (OTHER COMPLICATIONS.) SWELLING = (B)(4). DEVICE LABELING REVIEWED: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL FOR PTS IN THE (B)(4) STUDY INCLUDED IN THE LABELING FOR SALINE BREAST IMPLANTS.

    Description of Event or Problem · 1

    THROUGH MY RESEARCH REVIEW AS RN PRODUCT SUPPORT SPECIALIST, THE FOLLOWING ARTICLE CAME TO MY ATTENTION: "SEROMA-ASSOCIATED PRIMARY ANAPLASTIC LARGE-CELL LYMPHOMA ADJACENT TO BREAST IMPLANTS: AN INDOLENT T-CELL LYMPHOPROLIFERATIVE DISORDER". (MODEM PATHOLOGY (2008) 21, 455-463).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SALINE IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM UNKNOWN MANUFACTURER NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention NO INFORMATION| NO INFORMATION