BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLSEN

    MDR report key: 126879 · Received October 17, 1997

    Report

    Report Number
    2916288-1997-00005
    Event Type
    Injury
    Date Received
    October 17, 1997
    Report Date
    October 17, 1997
    Manufacturer
    OLSEN ELECTROSURGICAL, INC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT SUFFERED A BURN DURING AN UNKNOWN PROCEDURE. THE DISTRIBUTOR NOTIFIED THE MANUFACTURER OF THE EVENT, REQUESTED MATERIALS INFORMATION, AND PROMISED FOLLOW-UP ON THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLSEN UNKNOWN FORCEPS GEI OLSEN ELECTROSURGICAL, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other