BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT SMART RELIEF TENS THERAPY

    MDR report key: 3940206 · Received June 19, 2014

    Report

    Report Number
    1022556-2014-73171
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    May 26, 2014
    Manufacturer
    CHATTEM, INC.
    Product Code
    NUH
    PMA / PMN Number
    K131159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENT DATED (B)(4) 2014: ALTHOUGH THE CAUSAL ROLE OF ICY HOT SMART RELIEF TENS THERAPY CANNOT BE RULED OUT FOR PUT THIS ON MY BACK AND I'M BLISTERED, BAD, HOWEVER, THE CASE LACKS INFO PRECISE DATED DRUG HISTORY, ON INVESTIGATION FOR NON-DRUG CAUSES, COMPLETE MEDICAL HISTORY, CONCOMITANT MEDICATIONS (IF ANY), CONCURRENT CONDITIONS IF ANY) TO ALLOW A MORE PROPER CAUSALITY ASSESSMENT.

    Description of Event or Problem · 1

    INITIAL INFO REGARDING THIS SERIOUS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED FROM THE PT ON (B)(6) 2014. THIS CASE INVOLVING A FEMALE PT OF UNK AGE WHO COMPLAINED THAT SHE PUT SMART RELIEF TENS THERAPY (ICY HOT SMART RELIEF TENS THERAPY STARTER KIT BACK) ON HER BACK AND IT WAS BLISTERED BADLY. NO RELEVANT MEDICAL HISTORY, PAST DRUGS, RELEVANT CONCOMITANT MEDICATIONS OR CONCURRENT CONDITION WAS REPORTED. ON AN UNK UNSPECIFIED DATE, THE PT STARTED USING SMART RELIEF TENS THERAPY (LOT/BATCH NUMBER AND EXPIRATION DATE: NOT PROVIDED). AFTER AN UNK DURATION OF USE, ON A DATE NOT MENTIONED, SHE PUT SMART RELIEF TENS THERAPY ON HER BACK AND SHE COMPLAINED THAT IT WAS BLISTERED. ACTION TAKEN: UNK. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: UNK. THIS CASE WAS ASSESSED AS SERIOUS DUE TO MEDICALLY SIGNIFICANT EVENT OF "PUT THIS ON MY BACK AND I'M BLISTERED, BAD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359468 ICY HOT SMART RELIEF TENS THERAPY TRANSCUTANEOUS NERVE STIMULATOR NUH CHATTEM, INC. UNK

    Patients

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