BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEONATAL REM POLYHESIVE II

    MDR report key: 485850 · Received September 30, 2003

    Report

    Report Number
    485850
    Event Type
    Other
    Date Received
    September 30, 2003
    Date of Event
    September 1, 2002
    Report Date
    October 1, 2002
    Manufacturer
    VALLEYLAB, DIV OF TYCO HEALTHCARE GROUP LP
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE SURGICAL TEAM REQUESTED A BOVIE PAD, THAT WAS INTENDED FOR A ONE TO SIX POUND PT, BE PLACED ON A PT, WEIGHING ALMOST EIGHT POUNDS. THERE WAS NO HARM TO THE PT, BUT WHEN QUESTIONED ABOUT THE USE OF THE PAD, THE PHYSICIAN STATED THAT THE BOVIE PAD RECOMMENDED BY THE MFR IS TOO BIG AND HAD A CLIP CONNECTOR THAT CAUSES UNDUE PRESSURE ON THE PT'S SKIN. THE PAD ALSO WRAPS AROUND THE WHOLE TRUNK AND HAS THE POTENTIAL TO TRAP THE PREP SOLUTIONS AS WELL AS INTERFERE WITH THE SURGERY. SURGERY TIME WAS NOT DELAYED. THE SURGERY TEAM WAS PROPERLY ORIENTED ON THE USE OF THE DEVICE. THIS IS THE FIRST INCIDENT REPORT RECEIVED ABOUT THE SIZE OF THE BOVIE PAD, BUT APPARENTLY THE SURGEONS HAVE ADOPTED THE USE OF THE SMALLER PAD DUE TO THE PROBLEMS WITH THE LARGER PADS. THE MFR'S REP HAS BEEN MADE AWARE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEONATAL REM POLYHESIVE II NEONATAL PATIENT RETURN ELECTRODE GEI VALLEYLAB, DIV OF TYCO HEALTHCARE GROUP LP * 60735 2004-05

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Other ELECTROSURGICAL UNIT.