BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANODYNE THERAPY

    MDR report key: 687359 · Received March 10, 2006

    Report

    Report Number
    1055581-2006-00024
    Event Type
    Injury
    Date Received
    March 10, 2006
    Date of Event
    January 23, 2006
    Report Date
    March 10, 2006
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    ILY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE A PT AT A LONG TERM CARE FACILITY, RECEIVING THERAPY FOR POST HIP REPLACEMENT, PATIENT IS REPORTED TO HAVE DEVELOPED NECROTIC TISSUE AT A SURGICAL INCISION SITE, AND PATIENT'S SURGEON ADMITTED PATIENT TO THE HOSPITAL FOR FURTHER TREATMENT. THIS EVENT OCCURRED WITHIN 24 HOURS OF PATIENT RECEIVING ONE TREATMENT WITH THE ANODYNE PROFESSIONAL UNIT, THAT WAS ADMINISTERED BY A HEALTH CARE PROFESSIONAL. TREATMENT RECORDS DESCRIBE THAT THIS PATIENT HAD EXPERIENCED AND WAS BEING TREATED FOR POST SURGICAL HEALING DIFFICULTIES. WE HAVE NO CONCLUSIVE INFORMATION THAT INDICATES THE ANODYNE UNIT CAUSED OR CONTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANODYNE THERAPY INFRARED LAMP ILY ANODYNE THERAPY, LLC 480 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization