BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT SMART RELIEF TENS BACK PAIN THERAPY

    MDR report key: 6289732 · Received January 31, 2017

    Report

    Report Number
    1022556-2017-00001
    Event Type
    Injury
    Date Received
    January 31, 2017
    Report Date
    January 22, 2017
    Manufacturer
    CHATTEM
    Product Code
    NUH
    PMA / PMN Number
    K131159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INITIAL INFORMATION REGARDING THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON 22-JAN-2017 FROM THE PATIENT. THIS CASE INVOLVES A FEMALE PATIENT OF UNKNOWN AGE WHO HAD TERRIBLE BLISTERS ON HER BACK, AN UNKNOWN DURATION AFTER INITIATING TREATMENT WITH SMART RELIEF TENS THERAPY (ICY HOT SMART RELIEF TENS BACK PAIN THERAPY). NO PAST DRUGS, RELEVANT MEDICAL HISTORY, CONCURRENT CONDITIONS OR CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNSPECIFIED DATE, THE PATIENT STARTED USING SMART RELIEF TENS THERAPY (FREQUENCY, LOT/BATCH NUMBER AND EXPIRATION DATE: UNKNOWN) FOR BACK PAIN. ACCORDING TO THE PATIENT, IT RELEASED SOME OF THE PAIN. IT WAS FOR BACK AND HIP. ON AN UNKNOWN DATE, THE PATIENT PUT IT ON HER BACK AND PUSHED THE PLUS AND SAT IN THE CHAIR. SHE IMMEDIATELY FELT LIKE SOMETHING POKING HER IN THE BACK. SHE REMOVED THE PATCH AND OBSERVED TERRIBLE BLISTERS ON HER BACK (LATENCY: UNSPECIFIED). THE PATIENT HAD BEEN IN PAIN FROM THIS. ACTION TAKEN: UNKNOWN. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: UNKNOWN. SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT.

    Description of Event or Problem · 1

    INITIAL INFORMATION REGARDING THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON 22-JAN-2017 FROM THE PATIENT. THIS CASE INVOLVES A FEMALE PATIENT OF UNKNOWN AGE WHO HAD TERRIBLE BLISTERS ON HER BACK, AN UNKNOWN DURATION AFTER INITIATING TREATMENT WITH SMART RELIEF TENS THERAPY (ICY HOT SMART RELIEF TENS BACK PAIN THERAPY). NO PAST DRUGS, RELEVANT MEDICAL HISTORY, CONCURRENT CONDITIONS OR CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNSPECIFIED DATE, THE PATIENT STARTED USING SMART RELIEF TENS THERAPY (FREQUENCY, LOT/BATCH NUMBER AND EXPIRATION DATE: UNKNOWN) FOR BACK PAIN. ACCORDING TO THE PATIENT, IT RELEASED SOME OF THE PAIN. IT WAS FOR BACK AND HIP. ON AN UNKNOWN DATE, THE PATIENT PUT IT ON HER BACK AND PUSHED THE PLUS AND SAT IN THE CHAIR. SHE IMMEDIATELY FELT LIKE SOMETHING POKING HER IN THE BACK. SHE REMOVED THE PATCH AND OBSERVED TERRIBLE BLISTERS ON HER BACK (LATENCY: UNSPECIFIED). THE PATIENT HAD BEEN IN PAIN FROM THIS. ACTION TAKEN: UNKNOWN. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: UNKNOWN. SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT. QA REVIEW FINDINGS: THE CONSUMER STATED THAT THEY EXPERIENCED PAINFUL BLISTERS AFTER USING THE DEVICE ON THEIR BACK. A THOROUGH INVESTIGATION ((B)(4), CAPA PROTOCOL AND REVIEW OF IHSR [2014]) HAS BEEN DONE TO INVESTIGATE THE LIKELIHOOD OF THE IHSR PRODUCING BURNS IN SOME USERS. THIS INVESTIGATION FOUND THAT IT IS HIGHLY UNLIKELY FOR THE SMART RELIEF TO PRODUCE TISSUE TRAUMA. THE MAXIMUM CURRENT AND POWER DENSITY CALCULATED FOR THE SMART RELIEF IS A TINY FRACTION OF THE LIMITS IN THE FDA GUIDANCE. THE COMPLETE INVESTIGATION IS LOCATED IN THE DEVICE FILES. LOT INFORMATION WAS NOT PROVIDED AT THIS TIME. AWAITING FURTHER CORRESPONDENCE AND DEVICE RETURN FOR ADDITIONAL INVESTIGATION. ADDITIONAL INFORMATION WAS RECEIVED ON 25-JAN-2017 FROM QUALITY DEPARTMENT, QA REVIEW FINDING ADDED. TEXT AMENDED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74217 ICY HOT SMART RELIEF TENS BACK PAIN THERAPY TRANSCUTANEOUS NERVE STIMULATOR NUH CHATTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other