BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT SMART RELIEF TENS BACK PAIN THERAPY

    MDR report key: 5191136 · Received October 30, 2015

    Report

    Report Number
    1022556-2015-78219
    Event Type
    Injury
    Date Received
    October 30, 2015
    Report Date
    October 22, 2015
    Manufacturer
    CHATTEM, INC.
    Product Code
    NUH
    PMA / PMN Number
    K131159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INITIAL INFORMATION REGARDING THIS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED FROM THE PATIENT ON (B)(6) 2015. THIS CASE INVOLVES A FEMALE PATIENT OF UNKNOWN AGE, WHO COMPLAINED THAT SMART RELIEF TENS THERAPY (ICY HOT SMART RELIEF TENS BACK PAIN THERAPY) BURNT HER BACK TO THE POINT SHE GOT A BLISTER ALSO IN JUST 30 MIN, (LATENCY: UNKNOWN). PAST DRUGS, MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON UNKNOWN DATE, THE PATIENT STARTED THERAPY WITH SMART RELIEF TENS THERAPY AT AN UNSPECIFIED FREQUENCY (LOT/BATCH NUMBER: 15C106 AND EXPIRY DATE: 28-FEB-2017) FOR BACK DISORDER. CONTROL UNIT SERIAL NUMBER (B)(4), ELECTRODE PAD LOT NUMBER 14082001 AND EXPIRY DATE WAS FEB-2017. THE PATIENT REPORTED THAT SHE LIKE THIS PRODUCT BUT IT BURNT HER BACK TO THE POINT SHE GOT A BLISTER ALSO IN JUST 30 MIN (ONSET DATE AND LATENCY: UNKNOWN). THE PATIENT WANTED TO KNOW ABOUT THE PRODUCT. ACTION TAKEN: UNKNOWN. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: UNKNOWN. SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT QA REVIEW FINDINGS: RECEIVED ONE TENS UNIT SERIAL NUMBER (B)(4), ONE PANASONIC BATTERY, AND ONE ELECTRODE FROM LOT NUMBER 14082001 FOR EVALUATION. THE UNIT WAS FULLY FUNCTIONAL WITH BOTH THE RECEIVED AND A NEW BATTERY; COMPLETE AND CONSISTENT STIMULATION WAS PRESENT. THERE WAS NO UNUSUAL OR ERRATIC OPERATION NOTED. THE ELECTRODE WAS IN AVERAGE CONDITION AND STORED ON A CLEAR, PROTECTIVE SHEET; THERE WAS EVIDENCE OF USE BUT IT WAS WELL MAINTAINED. IT WAS CLEAN, NOT MISSING GEL, AND STICKY. THE LEFT IMPEDANCE READINGS WERE 600 OHM AND 610 OHM, AND THE RIGHT IMPEDANCE READINGS WERE 600 OHM AND 630 OHM. THESE HIGH IMPENDENCE READINGS AND OVERALL GOOD CONDITION INDICATE A FUNCTIONAL PAD. BECAUSE OF THE SEVERITY OF THE BURN CLAIM, THE PAD WAS INSPECTED FOR HOT SPOTS THAT WOULD REVEAL HIGH CONCENTRATED CURRENT DENSITIES. THERE WERE NO HOT SPOTS FOUND ON THE PAD; IMPEDANCE READINGS WERE UNIFORM. THEREFORE, THROUGH THIS INVESTIGATION, IT CAN BE CONFIRMED THAT THE ADVERSE EVENT THAT OCCURRED WAS NOT DUE TO A DEVICE MALFUNCTION OR DEFECT; THE DEVICE OPERATED WITHIN SPECIFICATION. THEREFORE, THERE WERE NO FAULTS FOUND WITH THIS DEVICE. FINAL CONCLUSION: NO FAULTS FOUND WITH THIS DEVICE ROOT CAUSE: NO FAULTS FOUND WITH THIS DEVICE FOLLOW UP WAS RECEIVED ON 28-OCT-2015: NO NEW INFORMATION WAS RECEIVED ADDITIONAL INFORMATION WAS RECEIVED ON 19-JAN-2016, QA REVIEW FINDINGS ADDED. TEXT AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT FOLLOW UP DATED 19-01-2016:THE FOLLOW UP INFORMATION RECEIVED DOES NOT CHANGE THE PRIOR MEDICAL ANALYSIS OF THE CASE. SANOFI COMPANY COMMENT DATED 28-10-2015:THIS CASE CONCERNS A FEMALE PATIENT OF UNKNOWN DEMOGRAPHY WHO EXPERIENCED APPLICATION SITE BURN AND BLISTERS AFTER APPLYING THE DEVICE SMART RELIEF TENS. ALTHOUGH THE CAUSAL ROLE OF SUSPECT DEVICE CANNOT BE FORMALLY EXCLUDED; HOWEVER LACK OF INFORMATION ABOUT THE CONDITION OF SKIN AT THE CONTACT AREA PRIOR TO APPLYING DEVICE PRECLUDES THE COMPREHENSIVE ASSESSMENT OF THE CASE.

    Description of Event or Problem · 1

    INITIAL INFORMATION REGARDING THIS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED FROM THE PATIENT ON (B)(6) 2015. THIS CASE INVOLVES A FEMALE PATIENT OF UNKNOWN AGE, WHO COMPLAINED THAT SMART RELIEF TENS THERAPY (ICY HOT SMART RELIEF TENS BACK PAIN THERAPY) BURNT HER BACK TO THE POINT SHE GOT A BLISTER ALSO IN JUST 30 MIN, (LATENCY: UNKNOWN). PAST DRUGS, MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON UNKNOWN DATE, THE PATIENT STARTED THERAPY WITH SMART RELIEF TENS THERAPY AT AN UNSPECIFIED FREQUENCY (LOT/BATCH NUMBER: 15C106 AND EXPIRY DATE: 28-FEB-2017) FOR BACK DISORDER. CONTROL UNIT SERIAL NUMBER (B)(4), ELECTRODE PAD LOT NUMBER 14082001 AND EXPIRY DATE WAS FEB-2017. THE PATIENT REPORTED THAT SHE LIKE THIS PRODUCT BUT IT BURNT HER BACK TO THE POINT SHE GOT A BLISTER ALSO IN JUST 30 MIN (ONSET DATE AND LATENCY: UNKNOWN). THE PATIENT WANTED TO KNOW ABOUT THE PRODUCT. ACTION TAKEN: UNKNOWN. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: UNKNOWN. SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED 28-10-2015:THIS CASE CONCERNS A FEMALE PATIENT OF UNKNOWN DEMOGRAPHY WHO EXPERIENCED APPLICATION SITE BURN AND BLISTERS AFTER APPLYING THE DEVICE SMART RELIEF TENS. ALTHOUGH THE CAUSAL ROLE OF SUSPECT DEVICE CANNOT BE FORMALLY EXCLUDED; HOWEVER LACK OF INFORMATION ABOUT THE CONDITION OF SKIN AT THE CONTACT AREA PRIOR TO APPLYING DEVICE PRECLUDES THE COMPREHENSIVE ASSESSMENT OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723320 ICY HOT SMART RELIEF TENS BACK PAIN THERAPY TRANSCUTANEOUS NERVE STIMULATOR NUH CHATTEM, INC. 15C106

    Patients

    Seq Age Sex Outcome Treatment
    1 Other