BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHORESOR II

    MDR report key: 647049 · Received October 28, 2005

    Report

    Report Number
    647049
    Event Type
    Other
    Date Received
    October 28, 2005
    Date of Event
    October 20, 2005
    Report Date
    October 28, 2005
    Manufacturer
    IOMED, INC.
    Product Code
    EGJ
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PROBLEM: AN OUTPATIENT WAS BEING TREATED WITH AN IONTOPHORESIS UNIT AT THE SPORTS MEDICINE DEPARTMENT WHEN THE PATIENT COMPLAINED OF A BURN ON THE PATIENT'S RIGHT UPPER TRAPEZOID WHERE THE PATIENT HAD BEEN PREVIOUSLY TREATED. THE PHYSICAL THERAPIST EXAMINED THE WOUND AND CONTINUED TREATMENT BUT AT A DIFFERENT LOCATION. AT THE CONCLUSION OF THAT TREATMENT, THE SKIN AT THE TREATMENT SITE APPEARED TO BE INTACT. HOWEVER, THE FOLLOWING DAY THE PATIENT CAME IN TO REPORT THAT THE WOUND HAD BEEN CLASSIFIED AS A SECOND DEGREE BURN BY THE NURSE AT THE PATIENT'S WORKPLACE. THE PHYSICAL THERAPIST ADVISED THE PATIENT TO FOLLOW UP WITH HER PHYSICIAN FOR WOUND CARE. THERE ARE TWO IONTOPHERESIS UNITS IN THE SPORTS MEDICINE DEPARTMENT. SINCE THE THERAPIST IS NOT SURE WHICH UNIT MAY HAVE CAUSED THE BURN, BOTH WERE REMOVED FROM SERVICE AND TURNED OVER TO BIOMEDICAL ENGINEERING FOR EXAMINATION. BIOMED ENGINEERING CONTACTED THE MANUFACTURER AND THEY SENT TWO REPLACEMENT UNITS. THE QUESTIONABLE UNITS WERE SENT BACK FOR ANALYSIS. WE HAVE REQUESTED THE MANUFACTURER INFORM US OF THEIR CONCLUSIONS. FOLLOW UP: PATIENT WAS SEEN BY THE SPORTS MEDICINE MANAGER WHO CONCLUDED THE WOUND WAS HEALING. PATIENT IS RECEIVING CARE AT WORK BY THE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHORESOR II IONTOPHORESIS DELIVERY UNIT EGJ IOMED, INC. PM700 *
    2 PHORESOR II IONTOPHORESIS DELIVERY UNIT EGJ IOMED, INC. PHORESOR II AUTO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *