BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LECTROVAC II 6-INCH

    MDR report key: 812162 · Received February 1, 2007

    Report

    Report Number
    1717344-2007-00032
    Event Type
    Injury
    Date Received
    February 1, 2007
    Date of Event
    December 15, 2006
    Report Date
    January 5, 2007
    Manufacturer
    VALLEYLAB, QA
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: TONSILECTOMY/T & A. REPORTEDLY, THE PATIENT ENDED UP WITH BURN ON THEIR TONGUE THAT SHOWED UP THE DAY AFTER SURGERY. PATIENT HAD TO BE ADMITTED FOR FLUIDS BECAUSE SHE WOULDN'T EAT. THE BURN DID NOT SHOW UP UNTIL AFTER SURGERY WAS DONE. PATIENT PROGRESS REPORTS STATES THAT THE PATIENT IS IN GOOD CONDITION AND IS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LECTROVAC II 6-INCH ELECTROSURGICAL ACCESSORY GEI VALLEYLAB, QA * 98345

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention