BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 7284417 · Received February 20, 2018

    Report

    Report Number
    3003464075-2018-00007
    Event Type
    Injury
    Date Received
    February 20, 2018
    Date of Event
    January 30, 2018
    Report Date
    February 20, 2018
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    FKR
    PMA / PMN Number
    K140571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETAINED FOR INVESTIGATION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED. BIOCOMPATIBILITY OF THE DEVICE HAS BEEN ESTABLISHED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ON (B)(6) 2018 REGARDING A (B)(6) -YEAR-OLD MALE PATIENT WHO WAS HOSPITALIZED FOR 14 DAYS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125628 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM FKR NXSTAGE MEDICAL, INC. SAK-304 70879045

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization