BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLSEN ELECTROSURGICAL INC.

    MDR report key: 237197 · Received August 23, 1999

    Report

    Report Number
    237197
    Event Type
    Malfunction
    Date Received
    August 23, 1999
    Date of Event
    August 19, 1999
    Report Date
    August 19, 1999
    Manufacturer
    OEI
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE USING BOVIE WITH AN OLSEN 4" REUSABLE EXTENSION DURING A BREAST AUGMENTATION A BURN WAS NOTED ON THE LATERAL ASPECT OF THE LEFT BREAST INCISION, UPON INSPECTION OF THE BOVIE A BARE AREA WAS NOTED ON THE SHODDED PART OF THE REUSABLE OLSEN 4" EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLSEN ELECTROSURGICAL INC. REUSABLE 4" SHOD BOVIE EXTENSION GEI OEI 675-4 031980

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other