BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPEN SURGICAL SYSTEMS

    MDR report key: 241787 · Received September 22, 1999

    Report

    Report Number
    1720159-1999-00112
    Event Type
    Injury
    Date Received
    September 22, 1999
    Date of Event
    August 18, 1999
    Report Date
    August 25, 1999
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPEN SURGICAL SYSTEMS ELECTROSURGICAL PENCIL GEI HAND-TROL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN FORCE 2, VALLEY LAB ESU- THE ESU CHECKED OUT TO BE| WORKING CORRECTLY.