BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS, INC.

    MDR report key: 512301 · Received January 26, 2004

    Report

    Report Number
    512301
    Event Type
    Injury
    Date Received
    January 26, 2004
    Date of Event
    January 23, 2004
    Report Date
    January 26, 2004
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING INSERTION OF "PERMA CATH", THE "PEEL AWAY" SHEATH FRACTURED, LEAVING A PIECE OF SHEATH LEFT IN THE PT, AROUND THE "PERMA CATH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIODYNAMICS, INC. PERMA CATHETER DQO ANGIODYNAMICS, INC. 10301202 M356620

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention