BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESCIO SILVER GUARD CATHETER

    MDR report key: 35241 · Received July 17, 1996

    Report

    Report Number
    35241
    Event Type
    Injury
    Date Received
    July 17, 1996
    Date of Event
    February 1, 1996
    Report Date
    February 8, 1996
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    LFJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BOTH LINES OF CATHETER BROKE OFF, REQUIRING SURGICAL REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESCIO SILVER GUARD CATHETER DIALYSIS CATHETER LFJ MEDICAL COMPONENTS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention