BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANODYNE THERAPY, LLC

    MDR report key: 1035283 · Received April 25, 2008

    Report

    Report Number
    MW5006451
    Event Type
    Malfunction
    Date Received
    April 25, 2008
    Date of Event
    August 28, 2007
    Report Date
    April 25, 2008
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    ILY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT TREATED WITH ANODYNE INFRARED PHOTO. TREATMENT PROTOCOL FOLLOWED WITH INSPECTION OF THE SKIN AREA TO BE TREATED. THE NEXT DAY, PATIENT CAME TO THE PT DEPARTMENT AND STATED, THAT HE HAD A BURN ON HIS SKIN WHERE THE TREATMENT WAS GIVEN. THE AREA SHOWED A SKIN TEAR AND A RED AREA MEASURING 4 X 2.5 CM. THE AREA WAS INSPECTED AND TREATED BY THE WOUND CARE NURSE. PATIENT INSTRUCTIONS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANODYNE THERAPY, LLC NONE ILY ANODYNE THERAPY, LLC NOT KNOWN OR STATED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other