BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS

    MDR report key: 5005261 · Received July 17, 2015

    Report

    Report Number
    5005261
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    April 21, 2015
    Report Date
    July 2, 2015
    Manufacturer
    ANGIODGNAMICS
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SHEATH FROM MICROINTRODUCER BROKE OFF AND PATIENT UNDERWENT A FLUOROSCOPIC GUIDED ARTERIAL FOREIGN BODY REMOVAL IN OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467152 ANGIODYNAMICS MICRO-INTRODUCER DYB ANGIODGNAMICS 4857386

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization