BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SALINE IMPLANT

    MDR report key: 1888850 · Received October 19, 2010

    Report

    Report Number
    2024601-2010-00809
    Event Type
    Death
    Date Received
    October 19, 2010
    Date of Event
    February 9, 2010
    Report Date
    February 9, 2010
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE LABELING ADDRESSES THE ADDRESSES THE REPORTED EVENT OF SEROMA AS FOLLOWS: (B)(4).

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS A CASE OF SEROMA AND ANAPLASTIC LARGE CELL LYMPHOMA (ALCL). F/U FINDINGS: PT HAS TEXTURED, SALINE BREAST IMPLANT, MFR UNK. ALLERGAN TAKES THE CONSERVATIVE APPROACH TO REPORTING. F/U FINDINGS: PT HAD WELL CARE APPOINTMENT TWO MONTHS AFTER MULTIPLE BIOPSIES, TWO DAYS LATER DEVELOPED BREAST SWELLING. PT THEN HAD A GENERAL SURGERY CONSULTATION AND EVAL WITH THREE PERCUTANEOUS DRAINAGE PROCEDURES AND BIOPSIES. DIAGNOSIS OF ALCL MADE. PRIMARY VS SECONDARY BREAST ALCL UNCLEAR, BUT STAGE IV AT DIAGNOSIS. MULTI-AGENT CHEMOTHERAPY PROVIDED; REFRACTORY TO CHEMOTHERAPY. MEDIASTINAL LYMPH NODES IDENTIFIED BY CT SCAN. F/U FINDINGS: PT HAD SUPRA CLAVICULAR AND AXILLARY NODES IN ADDITION TO PRESENTING WITH SWOLLEN BREAST. LIVER, CHEST WALL, MEDIASTINAL LYMPHADENOPATHY, RIGHT PLEURAL EFFUSION, LUNG NODULES, ABDOMINAL WALL, RETROPERITONEAL LYMPH NODES FINDINGS. INVESTIGATION CONTINUES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death| R