BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT SMART RELIEF TENS THERAPY

    MDR report key: 3913031 · Received June 11, 2014

    Report

    Report Number
    1022556-2014-73194
    Event Type
    Injury
    Date Received
    June 11, 2014
    Report Date
    May 28, 2014
    Manufacturer
    CHATTEM, INC.
    Product Code
    NUH
    PMA / PMN Number
    K131159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENT DATED (B)(4) 2014: ALTHOUGH THE CASUAL ROLE OF SMART RELIEF TENS THERAPY CANNOT BE RULED OUT FOR EVENT BURNED HOWEVER, THE CASE LACKS INFORMATION ON THE UNDERLYING CONDITION, TIME PERIOD FOR WHICH COMPANY PRODUCT WAS USED, PRECISE DATED DRUG HISTORY, ON INVESTIGATIONS FOR NON-DRUG CAUSES, COMPLETE MEDICAL HISTORY, CONCOMMITANT MEDICATIONS (IF ANY) TO ALLOW A MORE PROPER CASUALITY ASSESSMENT.

    Description of Event or Problem · 1

    INITIAL INFORMATION REGARDING THIS SERIOUS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS REPORTED BY A CONSUMER ON (B)(6) 2014: THIS CASE CONCERNS A (B)(6) MALE PATIENT WHO BURNED A WHOLE IN HIS SKIN, AN UNSPECIFIED TIME AFTER STARTING THERAPY WITH SMART RELIEF TENS THERAPY (ICY HOT SMART RELIEF TENS THERAPY). NO PAST DRUGS, RELEVANT MEDICAL HISTORY, CONCOMITANT MEDICATIONS AND CONCURRENT CONDITIONS WERE REPORTED. ON (B)(6) 2014, THE PATIENT PURCHASED AND STARTED USING THE SMART RELIEF TENS THERAPY (AS INSTRUCTED; LOT NUMBER AND EXPIRY DATE: NOT REPORTED). AFTER AN UNSPECIFIED TIME, ON AN UNKNOWN DATE, IT BURNED A HOLE IN HIS SKIN AND LEFT HIM WITH A SMALL, BUT PAINFUL ABRASION. HE MADE IT CLEAR, THIS IT WAS NOT SKIN IRRITATION. REPORTEDLY, THERE WERE TWO BURNED AREAS ON HIS LOWER BACK WHERE HE HAD USED THE DEVICE. IT WAS REPORTED THAT THERE WERE NO WARNINGS ABOUT BURNING WITH THE UNIT. ACTION TAKEN: UNK. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: UNK. SERIOUSNESS CRITERIA: IMPORTANT MED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344049 ICY HOT SMART RELIEF TENS THERAPY TRANSCUTANEOUS NERVE STIMULATOR NUH CHATTEM, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other PREV MEDS= UNK| CON MEDS= UNK