BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREFIT DISPERSIVE ELECTRODE

    MDR report key: 379993 · Received March 4, 2002

    Report

    Report Number
    1317214-2002-00012
    Event Type
    Other
    Date Received
    March 4, 2002
    Report Date
    February 4, 2002
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "FOLLOWING AN OUT PT SURGICAL PROCEDURE, THE PT REPORTED NUMBNESS AT THE GROUND PAD APPLICATION SITE. THERE WAS NO REPORT OF DAMAGE TO THE SKIN OR THE UNDERLYING TISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFIT DISPERSIVE ELECTRODE DISPERSIVE ELECTRODE GEI CONMED CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other PEGASUS ESU (2002 TO 2002).