BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED

    MDR report key: 271113 · Received March 24, 2000

    Report

    Report Number
    1720159-2000-00020
    Event Type
    Malfunction
    Date Received
    March 24, 2000
    Date of Event
    February 27, 2000
    Report Date
    February 28, 2000
    Manufacturer
    CONMED/ASPEN LABS
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR BURN: THE HYFRECATOR PENCIL SPARKED AND BURNED THE DR AND SHOCKED THE PT. THE SHOCK AND BURN WERE VERY MINOR. REFER TO MFR REPORT NUBMERS 1820159-2000-00021 AND 00022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED ELECTROSURGICAL PENCIL GEI CONMED/ASPEN LABS HYFRECATOR PLUS PENCIL 98BHH001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA