BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPEN SURGICAL SYSTEMS

    MDR report key: 310528 · Received December 28, 2000

    Report

    Report Number
    1720159-2000-00101
    Event Type
    Injury
    Date Received
    December 28, 2000
    Date of Event
    November 27, 2000
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPEN SURGICAL SYSTEMS ELECTROSURGICAL PENCIL GEI HAND-TROL 00JHA003

    Patients

    Seq Age Sex Outcome Treatment
    1