{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-05", "results": { "skip": 0, "limit": 1, "total": 118 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "NO INFORMATION", "report_to_fda": "I", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "MW5094268", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200424", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200423", "reprocessed_and_reused_flag": "I", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PATIENT", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "462382", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200424", "brand_name": "ICYHOT SMART RELIEF TENS THERAPY", "generic_name": "STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER", "manufacturer_d_name": "CHATTEM / SANOFI US SERVICES INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "LAY USER/PATIENT", "expiration_date_of_device": "20210630", "model_number": "SMARTRELIEF 1.0", "catalog_number": "0042298-03", "lot_number": "19L108", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "NUH", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00041167080450", "udi_public": "041167080450", "openfda": { "device_name": "Stimulator, Nerve, Transcutaneous, Over-The-Counter", "medical_specialty_description": "Neurology", "regulation_number": "882.5890", "device_class": "2" } } ], "product_problems": [ "Therapeutic or Diagnostic Output Failure" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250728", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200424", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "64 YR", "patient_sex": "", "patient_weight": "112", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200423", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000746", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Voluntary report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189171195", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE TENS UNIT DOESN'T WORK PROPERLY, AND IN RESEARCHING IT, THIS SEEMS TO BE A COMMON OCCURRENCE WITH THE ICYHOT SMART RELIEF SYSTEM. YOU ARE TO SNAP THE POWER UNIT ONTO ADHESIVE PAD, BUT WHILE ONE SNAPS AND GOES ON FINE, THE OTHER SIDE DOESN'T MATCH UP QUITE RIGHT SO YOU HAVE TO MOVE IT AROUND A LITTLE TO GET IT TO SNAP ON. THIS PUT A SMALL WRINKLE IN THE PAD BY BOTH SNAPS, VERY SLIGHTLY. WHEN YOU PLACE THE PAD ON THE BACK OR HIP, INSTEAD OF THE STIMULATION OF NERVES THAT SHOULD BE FELT, THERE IS A THUMPING FEELING LIKE SOMEONE TAPPING FINGER ON YOU COUPLED WITH INTERMITTENT STIMULATION SENSATION. TRYING TO USE THE BUTTON TO INCREASE TO THE 63 SETTINGS ALSO DOESN'T WORK BECAUSE IT FEELS LIKE THE THUMPING TAKES THE SETTING I TRIED TO USE BACK DOWN TO ZERO OVER AND OVER. I HAVE TRIED THIS 3 TIMES TODAY AND EACH TIME THIS HAS HAPPENED. THIS IS THE MAIN COMPLAINT WITH THIS TENS SYSTEM IN READING REVIEWS ON VARIOUS PLACES, THAT THE UNIT ELECTRODE AND POWER SYSTEM DOESN'T WORK CORRECTLY. FDA SAFETY REPORT ID# (B)(4)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }