BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DCYL 250

    MDR report key: 555014 · Received September 21, 2004

    Report

    Report Number
    MW1033592
    Event Type
    Malfunction
    Date Received
    September 21, 2004
    Date of Event
    September 1, 2004
    Report Date
    September 14, 2004
    Manufacturer
    DIOMED AXCAN
    Product Code
    MVG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    LASER TIP EMBEDDED INTO PT'S ESOPHAGUS AND BROKE OFF DURING PHOTO DYNAMIC THERAPY. PT RETURNED 2 DAYS LATER FOR SECOND PDT AND TIP WAS FOUND TO BE IN PT'S STOMACH. PT SHOULD BE ABLE TO PASS WITHOUT INCIDENT. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DCYL 250 CYLINDRICAL DIFFISER 5.0CM MVG DIOMED AXCAN 630PDT 040704

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other