BEUDAMED
    FDA Adverse Event Other Summary report: N

    VTC FIRM NEPHROSTOMY SYSTEM KIT

    MDR report key: 17946 · Received August 23, 1994

    Report

    Report Number
    17946
    Event Type
    Other
    Date Received
    August 23, 1994
    Date of Event
    August 17, 1994
    Report Date
    August 22, 1994
    Manufacturer
    MEDITECH, INC.
    Product Code
    LJE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING INSERTION OF NEPHROSTOMY TUBE, THE INTRODUCER WIRE BROKE AT THE WELD AT THE DISTAL END OF THE WIRE. THE SOFT TIP, 7-7.5 CM IN LENGTH, RETAINED IN KIDNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VTC FIRM NEPHROSTOMY SYSTEM KIT NEPHROSTOMY LJE MEDITECH, INC. 105165

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other