BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWTON

    MDR report key: 3951799 · Received July 2, 2014

    Report

    Report Number
    2937457-2014-01480
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 2, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K002892
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT'S PERITONEAL DIALYSIS NURSE REPORTED THE PATIENT DEVELOPED TOUCH CONTAMINATION PERITONITIS (STAPH EPIDERMIS). THE PATIENT'S EFFLUENT WAS CULTURED ON (B)(6) 2014, AND HE IS CURRENTLY BEING TREATED WITH ORAL AND INTRAPERITONEAL ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385850 NEWTON FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PD SOLUTION| LIBERTY TUBING,