BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIODYNAMICS

    MDR report key: 670860 · Received February 1, 2006

    Report

    Report Number
    1222625-2006-00001
    Event Type
    Other
    Date Received
    February 1, 2006
    Report Date
    January 31, 2006
    Manufacturer
    BIOLITEC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A FIBER OPTIC DELIVERY SYSTEM WAS BROKEN DURING A PROCEDURE AT HOSPITAL. BIOLITEC MANUFACTURES THE FIBER FOR ANGIODYNAMIC. A LETTER FROM THE HOSPITAL TO ANGIODYNAMICS STATES THERE IS NO KNOWN PT INJURY. BIOLITEC HAS CONTACTED THE HOSPITAL BUT HAS RECEIVED NO RESPONSE. IT APPEARS THAT THE BREAKAGE WAS DUE TO USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIODYNAMICS FIBER OPTIC LASER DELIVERY SYSTEM GEX BIOLITEC BFHF603 006-0015

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN