BEUDAMED
    FDA Adverse Event Summary report: N

    SONICATOR PLUS 994

    MDR report key: 2132595 · Received June 3, 2011

    Report

    Report Number
    2132595
    Date Received
    June 3, 2011
    Date of Event
    February 10, 2011
    Report Date
    May 17, 2011
    Manufacturer
    METTLER ELECTRONICS CORP
    Product Code
    IMG
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELECTRODES WERE PLACED ON PATIENT'S RIGHT ARM AND TREATMENT WAS STARTED. DURING THE TREATMENT, STAFF NOTICED PATIENT'S SKIN TURNED RED IN THE PLACE WHERE THREE OUT OF THE FOUR ELECTRODES WERE PLACED AND TREATMENT WAS STOPPED. PATIENT'S MOTHER MENTIONED THAT BEFORE THE VISIT, SHE HAD PUT OIL ON THE PATIENT'S SKIN. THE FOLLOWING WEEK THE PATIENT CAME IN WITH SMALL BURN MARKS WHERE THREE OF THE ELECTRODES HAD BEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONICATOR PLUS 994 MUSCLE STIMULATOR IMG METTLER ELECTRONICS CORP ME994 *

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR