BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ME994 SONICATOR PLUS

    MDR report key: 1202683 · Received October 16, 2008

    Report

    Report Number
    2013558-2008-00002
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    March 24, 2008
    Report Date
    October 13, 2008
    Manufacturer
    METTLER ELECTRONICS CORP.
    Product Code
    IMG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED A FIFTEEN MIN INTERFERENTIAL TREATMENT FOR ACHILLES CONTRACTURE, THAT MUSCLE STIMULATOR WAS SET AT PT'S COMFORT (ACTUAL INTENSITY NOT AVAILABLE). COLD PACKS WITH 2 TOWELS PLACED IN BETWEEN 2" SQUARE ELECTRODES (VALUE TRODES). DURING TREATMENT, PT DID NOT COMPLAIN OF DISCOMFORT. APPROX ONE AND A HALF HOURS AFTER TREATMENT, THE PT CALLED THE THERAPIST STATING THAT REDNESS AND BLISTERS WERE BEGINNING TO FORM IN THE AREA TREATMENT WAS PERFORMED. PER THERAPIST, THE UNIT WAS IMMEDIATELY REMOVED FROM SERVICE AND SENT FOR INSPECTION. APPROX ONE WEEK LATER, THE PT RETURNED WITH A SINGLE WOUND THAT WAS SHOWING EARLY SIGNS OF INFECTION. THE PT WAS REFERRED TO A WOUND CARE PHYSICIAN FOR FOLLOW-UP TREATMENT. THE PT THEN RECEIVED I & D TREATMENT (INCISION AND DRAIN). PER THERAPIST, THE PT IS FULLY HEALED WITH A SLIGHT DISCOLORATION, NO SKIN GRAPHS WERE REQUIRED. THE AREA AFFECTED WAS APPROX THE SIZE OF A QUARTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ME994 SONICATOR PLUS MUSCLE STIMULATOR & ULTRASOUND THERAPY IMG METTLER ELECTRONICS CORP. ME994

    Patients

    Seq Age Sex Outcome Treatment
    1 Other