BEUDAMED
    FDA Adverse Event Other Summary report: N

    VULCAN GENERATOR

    MDR report key: 379040 · Received February 25, 2002

    Report

    Report Number
    2953127-2002-00004
    Event Type
    Other
    Date Received
    February 25, 2002
    Date of Event
    February 5, 2002
    Report Date
    February 15, 2002
    Manufacturer
    ORATEC INTERVENTIONS, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY THE GENERATOR ALARM WAS GOING ON AND OFF. THE GROUND PAD WAS CHECKED AND FOUND TO BE LOOSE. THE PAD WAS REPLACED. AFTER SURGERY IT WAS OBSERVED THAT THE PATIENT HAD A "REDDENED AREA" ON THE RIGHT LATERAL SIDE OF THE ABDOMEN WHERE THE GROUND PAD HAD BEEN PLACED. THE AREA WAS TREATED WITH TRIPLE ANTIBIOTIC AND A COLD COMPRESS. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention