BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB ELECTROCAUTERY REM PAD

    MDR report key: 1193644 · Received October 8, 2008

    Report

    Report Number
    MW5008590
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    August 19, 2008
    Report Date
    October 8, 2008
    Manufacturer
    VALLEYLAB
    Product Code
    ODR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A ELECTROCAUTERY UNIT WAS USED DURING A CYSTOSCOPY/HYSTERECTOMY. THE OPERATING ROOM STAFF REPORTED THAT THEY HAD TO USE FIVE REM PADS BEFORE SUFFICIENT GROUNDING WAS ACHIEVED. THE PATIENT APPEARED TO HAVE A SLIGHT REACTION TO THE ADHESIVE AROUND THE PADS. THERE WAS NO BURNS OR DAMAGE NOTED TO THE SKIN. THEY FINALLY HAD TO PLACE THE REM PAD TO THE LEFT ARM TO ACQUIRE SUFFICIENT GROUNDING. THE THIGHS WERE USED FIRST AND THE PADS FAILED TO PRODUCE SUFFICIENT GROUNDING. NO SPECIFIC LOT NUMBERS WERE NOTED, AND THE PADS WERE NOT SAVED TO RETURN TO THE COMPANY FOR EVALUATION. THE MACHINE WAS CHECKED BY CLINICAL ENGINEERING AND NO DEFECTS WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALLEYLAB ELECTROCAUTERY REM PAD BOVIE PAD ODR VALLEYLAB

    Patients

    Seq Age Sex Outcome Treatment
    1