BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLSEN

    MDR report key: 82555 · Received April 4, 1997

    Report

    Report Number
    2916288-1997-00002
    Event Type
    Injury
    Date Received
    April 4, 1997
    Report Date
    April 4, 1997
    Manufacturer
    OLSEN ELCTROSURGICAL, INC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING AN AUGMENTATION PROCEDURE, THE INSTRUMENT WAS INSERTED INTO A POCKET OF SKIN AND ACTIVATED. THE PHYSICIAN REPORTED BURNING OCCURRED IN AN AREA ABOVE THE TIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLSEN MONOPOLAR FORCEPS GEI OLSEN ELCTROSURGICAL, INC 120 E 016684

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other