BEUDAMED
    FDA Adverse Event Other Summary report: N

    VULCAN RF GENERATOR

    MDR report key: 378990 · Received February 25, 2002

    Report

    Report Number
    2953127-2002-00003
    Event Type
    Other
    Date Received
    February 25, 2002
    Date of Event
    January 29, 2002
    Report Date
    February 14, 2002
    Manufacturer
    ORATEC INTERVENTIONS, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SUB-ACROMIAL DECOMPRESSION PROCEDURE, THE PATIENT SUFFERED A GROUND PAD BURN. THE GROUND PAD (VALLEY LAB) WAS PLACED ON FATTY TISSUE OF THE INNER THIGH. THE BURN WAS APPROXIMATELY 2.5 X 1.5 CM. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VULCAN RF GENERATOR RF GENERATOR GEI ORATEC INTERVENTIONS, INC. 815000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention