BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVOL INC

    MDR report key: 86949 · Received April 25, 1997

    Report

    Report Number
    1213643-1997-00040
    Event Type
    Injury
    Date Received
    April 25, 1997
    Date of Event
    February 14, 1997
    Report Date
    April 25, 1997
    Manufacturer
    DAVOL, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT BURNED-DETERMINED TO BE USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVOL INC ELECTROSURGICAL UNIT GEI DAVOL, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention