BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLSEN

    MDR report key: 208160 · Received January 29, 1999

    Report

    Report Number
    2916288-1998-00001
    Event Type
    Injury
    Date Received
    January 29, 1999
    Report Date
    January 21, 1999
    Manufacturer
    OLSEN ELECTROSURGICAL, INC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A BREAST AUGMENTATION, THE PT WAS BURNED AROUND THE NIPPLE/AREOLA AREA INADVERTANTLY. THE DR STATES THAT THE INSULATION JUST ABOVE THE NEEDLE FOR SOME REASON OR OTHER BURNED THROUGH AT A LEVEL WHERE AN EXTERNAL BURN WOUND ON THE SKIN WAS CREATED. THE DR ALSO STATES THAT THEY HAVE TRIED TO PROTECT THE INSULATED NEEDLES AND THE CONNECTION TO THE HANDLE WITH RED FRENCH CATHETERS. THE DR REPORTS THAT ANOTHER INJURY OF THIS NATURE OCCURRED WITH THIS DEVICE RECENTLY. DR NOTES THAT BURN WAS CORRECTED WITH MINOR SURGERY AND PERMANENT SCARRING WAS NOT ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLSEN DISPOSABLE NEEDLE ELECTRODE GEI OLSEN ELECTROSURGICAL, INC. 970-6 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other