BEUDAMED
    FDA Adverse Event Other Summary report: N

    VALLEYLAB REM POLYHESIVE II

    MDR report key: 564371 · Received November 29, 2004

    Report

    Report Number
    MW1034202
    Event Type
    Other
    Date Received
    November 29, 2004
    Date of Event
    August 10, 2004
    Report Date
    November 29, 2004
    Manufacturer
    TYCO HEALTHCARE GROUP LP
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED BURNS TO THE INNER THIGHS WHICH MAY HAVE BEEN A COMPLICATION DUE TO THE LENGTH OF THE PROCEDURE COMBINED WITH THE PARTICULAR POSITIONING REQUIRED FOR A LIVER ABLATION. THE VALLEYLAB REM POLYHESIVE II PT RETURN ELECTRODE WAS USED WITH THE RF 3000 RADIOFREQUENCY GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALLEYLAB REM POLYHESIVE II PATIENT RETURN ELECTRODE GEI TYCO HEALTHCARE GROUP LP * 86442

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other