BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLADE ELECTRODE

    MDR report key: 1474609 · Received September 9, 2009

    Report

    Report Number
    1530493-2009-00007
    Event Type
    Other
    Date Received
    September 9, 2009
    Date of Event
    July 26, 2009
    Report Date
    September 9, 2009
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K973234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE HAD SCARRING AND SCRATCHES, EVIDENCE OF BEING ABRASIVELY CLEANED. THE END-USER EXPOSED THE DEVICE TO ABRASIVE CLEANING AND DETERIORATED THE INSULATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO OLSEN MEDICAL ON (B) (6)2009, DURING A TONSILLECTOMY A PT, PT INFO UNK, RECEIVED A MINOR BURN TO THEIR INSIDE LIP. THERE WERE NO REMEDIAL OR FOLLOW-UP TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADE ELECTRODE SINGLE USE BLADE ELECTRODE GEI OLSEN MEDICAL 30-0011 012732

    Patients

    Seq Age Sex Outcome Treatment
    1 Other