BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SALINE IMPLANT

    MDR report key: 3642247 · Received February 7, 2014

    Report

    Report Number
    2024601-2012-01301
    Event Type
    Injury
    Date Received
    February 7, 2014
    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
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS INITIALLY SUBMITTED VIA (B)(4), (B)(4) 2010, WITH THE TERM CODES SEROMA AND CANCER. CORRECTED UPDATE TO OUR SAFETY DATA BASE FOR THIS REPORTED EVENT NOTES THAT THE TERM CODE HAS BEEN CHANGED FROM CANCER TO LYMPHOMA - ALCL, DUE TO INCREASED SPECIFICITY. DEVICE LABELING REVIEWED: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL FOR PTS IN THE A95/R95 STUDY INCLUDED IN THE LABELING FOR SALINE BREAST IMPLANTS.

    Description of Event or Problem · 1

    LITERATURE REVIEW: "SEROMA-ASSOCIATED PRIMARY ANAPLASTIC LARGE-CELL LYMPHOMA ADJACENT TO BREAST IMPLANTS: AN INDOLENT T-CELL LYMPHOPROLIFERATIVE DISORDER, RODEN ET AL. MODERN PATHOLOGY (2008) 21, 455-463. THIS SUBMISSION IS FOR THE REPORTED CLINICAL FINDINGS PT 1. ALTHOUGH THE MFR OF THE DEVICE IS UNK, IT IS ALLERGAN'S APPROACH TO COMPLIANCE TO RESOLVE ALL DOUBT IN FAVOR OR REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80672 UNK SALINE IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM UNKNOWN MANUFACTURER NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention