BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEO-STAR PHORESIS CATHETER

    MDR report key: 65572 · Received January 2, 1997

    Report

    Report Number
    65572
    Event Type
    Injury
    Date Received
    January 2, 1997
    Date of Event
    June 4, 1996
    Report Date
    July 8, 1996
    Manufacturer
    NEOSTAR MEDICAL TECHNOLOGIES, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD CENTRAL CATHETER PLACED. ADMITTED 4/2/96 WITH INFECTED CATHETER; TREATED WITH ANTIBIOTICS AND DISCHARGED. 6/2/96 ADMITTED WITH DISCOLORATION OF SKIN AT SITE OF CATHETER, ELEVATED TEMP, C/O BURNING AND PAIN. 6/4/96 TO OR FOR REMOVAL OF INFECTED CENTRAL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEO-STAR PHORESIS CATHETER Implant CENTRAL LINE CATHETER DQO NEOSTAR MEDICAL TECHNOLOGIES, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R