BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT SMART RELIEF TENS THERAPY

    MDR report key: 3940208 · Received June 19, 2014

    Report

    Report Number
    1022556-2014-75636
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    June 2, 2014
    Manufacturer
    CHATTEM, INC.
    Product Code
    NUH
    PMA / PMN Number
    K131159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SERIOUS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED ON (B)(6) 2014 FROM THE PATIENT. THIS CASE INVOLVES A MALE PATIENT OF UNKNOWN AGE WHO FELT A SHOCK AFTER AN UNKNOWN DURATION OF COMMENCING SMART RELIEF TENS THERAPY (ICY HOT SMART RELIEF TENS THERAPY STARTER KIT BACK). THE PATIENT HAD A SIGNIFICANT MEDICAL HISTORY OF HIP REPLACEMENT. NO RELEVANT PAST DRUGS, RELEVANT CONCOMITANT MEDICATIONS OR CONCURRENT CONDITION WAS REPORTED. ON A DATE NOT SPECIFIED, THE PATIENT STARTED TO USE SMART RELIEF TENS THERAPY. THE PATIENT HAD A HIP REPLACEMENT WHICH CONTAINS METAL AND USES SMART RELIEF TENS THERAPY (DEVICE USE ERROR). AFTER AN UNKNOWN DURATION OF USE, ON A DATE NOT MENTIONED, HE HAS FELT A SHOCK WHEN REPOSITIONING THE PAD BEFORE. ACTION TAKEN: UNK. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: UNK. THE CASE WAS ASSESSED AS SERIOUS DUE TO AN IMPORTANT MEDICAL EVENT OF "FELT A SHOCK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359582 ICY HOT SMART RELIEF TENS THERAPY TRANSCUTANEOUS NERVE STIMULATOR NUH CHATTEM, INC. UNK

    Patients

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