BEUDAMED
    FDA Adverse Event Summary report: N

    QED

    MDR report key: 2622309 · Received June 8, 2012

    Report

    Report Number
    2622309
    Date Received
    June 8, 2012
    Date of Event
    May 31, 2012
    Report Date
    June 8, 2012
    Manufacturer
    SUN NUCLEAR CORPORATION
    Product Code
    IYE
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT COMPLAINED OF A BURNING FEELING DURING THE TREATMENT, AND WHEN THE DOCTOR LOOKED OVER THE PATIENT HE NOTICED A FEW BURN MARKS IN THE AREAS WHERE THE RADIATION DOSIMETER DIODES WERE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QED DOSIMETER, RADIATION, DIODE DETECTOR IYE SUN NUCLEAR CORPORATION 1136 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR