BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANODYNE THERAPY

    MDR report key: 4827570 · Received June 3, 2015

    Report

    Report Number
    1055581-2015-00001
    Event Type
    Injury
    Date Received
    June 3, 2015
    Date of Event
    May 7, 2015
    Report Date
    May 11, 2015
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    ILY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANODYNE THERAPY CONTACTED TREATING FACILITY TO DISCUSS THE REPORTS MADE BY THE PT. FACILITY PROVIDED SOAP NOTES AND TREATMENT PROTOCOLS WHICH DOD NOT SUPPORT A TOPICAL BURN OR ANY OTHER INJURY. FACILITY WAS REQUESTED TO IDENTIFY THE ANODYNE SYSTEM USED DURING TREATMENT, AND RETURN IT ANODYNE FOR EVAL, BUT HAS FAILED TO DO SO. FOLLOW UP CALLS WERE MADE TO SCHEDULE ADD'L TRAINING FOR FACILITY USERS AS IS OUR NORMAL PRACTICE. ALL CALLS WERE NOT RETURNED, AND FACILITY STATED WE WERE NOT TO CONTACT STAFF MEMBERS. IN SUMMATION, NO EVIDENCE HAS BEEN PROVIDED TO CONFIRM A TOPICAL BURN HAS OCCURRED, OR THAT ANODYNE THERAPY CONTRIBUTED TO THE REPORTED EVENT. WE DO NOT ANTICIPATE RECEIVING ANY FURTHER INFO TO CONTINUE AN INVESTIGATION, HOWEVER IF WE DO, WE WILL REPORT AS APPROPRIATE. PT REPORTS SHE IS CURRENTLY 90-95% HEALED.

    Description of Event or Problem · 1

    PT ADVISES THAT SHE RECEIVED A TOPICAL BURN FOLLOWING TREATMENT WITH ANODYNE THERAPY ADMINISTERED BY A HEALTHCARE PROFESSIONAL. THIS WAS THE 11TH TREATMENT RECEIVED, WITH NO PRIOR PROBLEMS. PT REPORTS SHE WENT TO THE ER FOR TREATMENT 2 DAYS FOLLOWING THIS ANODYNE TREATMENT. PT PROVIDED THE ER NOTES WHICH CONFIRM ABSENCE OF TREATMENT CONSISTENT WITH A TOPICAL BURN, IE NO TOPICAL TREATMENT AND NO WOUND COVERING. ER NOTES DO NOT MENTION A THERMAL INJURY, RATHER THAT PT WAS TREATED FOR CELLULITES WITH ANTIBIOTICS AND PAIN MEDICATION. PT ALSO PROVIDED VISUAL EVIDENCE THAT DOES NOT SHOW A TOPICAL BURN, RATHER MULTIPLE SKIN RED MARKS COVERING BOTH LEGS IN PLACES WHERE ANODYNE PADS WERE NOT PLACED BASED UPON BOTH CLINICAL PROTOCOLS AND SOAP NOTES FROM THE TREATING FACILITY / PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360726 ANODYNE THERAPY INFRARED DEVICE ILY ANODYNE THERAPY, LLC 480 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization