BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED

    MDR report key: 233421 · Received July 23, 1999

    Report

    Report Number
    1720159-1999-00057
    Event Type
    Malfunction
    Date Received
    July 23, 1999
    Report Date
    June 29, 1999
    Manufacturer
    ASPEN LABORATORIES, INC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL BIOMED TESTED THE SYSTEM 4400 ESU, A SAMPLE CONMED PENCIL, #130307,AND PAD. THE MFR OF THE PAD WAS UNKNOWN. THE PENCIL AND ESU TESTED OUT TO BE WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED ELECTROSURGICAL PENCIL GEI ASPEN LABORATORIES, INC. CONMED PENCIL 9903081

    Patients

    Seq Age Sex Outcome Treatment
    1 * DISPERSIVE ELECTRODE-MFG UNK.