BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMOND VIEW FIBER OPTIC PANEL

    MDR report key: 273652 · Received April 14, 2000

    Report

    Report Number
    1038548-2000-00003
    Event Type
    Injury
    Date Received
    April 14, 2000
    Date of Event
    January 26, 2000
    Report Date
    February 23, 2000
    Manufacturer
    GENZYME SURGICAL PRODUCTS CORP.
    Product Code
    GAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT ALLEGED THAT THE CYLINDRICAL PORTION OF THE LIGHT PANEL BECAME HOT DUE TO THE INTENSE LIGHT. THE PT INCURRED A 2ND DEGREE BURN AS A RESULT OF THE PHYSICIAN BRIEFLY RESTING THE INSTRUMENT ON THE PT'S SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMOND VIEW FIBER OPTIC PANEL FIBER OPTIC PANEL GAD GENZYME SURGICAL PRODUCTS CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other