{ "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": "2026-07-07", "results": { "skip": 0, "limit": 1, "total": 650020 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "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": "Injury", "report_number": "MW5005533", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080212", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20070814", "reprocessed_and_reused_flag": "N", "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": "20080225", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080212", "brand_name": "THERMACARE BACK AND HIP", "generic_name": "HEATWRAPS", "manufacturer_d_name": "PROCTER & GAMBLE", "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": "0", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "IMD", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Pack, Hot Or Cold, Disposable", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.5710", "device_class": "1" } } ], "product_problems": [ "Unknown (for use when the device problem is not known)" ], "reporter_state_code": "WV", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250827", "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": "20080212", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "70", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Scarring", "Burning Sensation", "Burn, Thermal", "Treatment with medication(s)" ] } ], "distributor_city": "", "date_report": "20080212", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1000008", "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": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "16108002", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "WHILE ON A TRIP, I BEGAN HAVING LOWER BACK PROBLEMS WHILE IN OUR CAR. WHEN WE GOT TO THE CITY AND MET UP WITH FAMILY, WE BEGAN A WALKING TOUR. MY BACK WAS REALLY BOTHERING ME, SO I BEGAN USING THERMACARE FOR BACK WRAP. I HAVE USED IT BEFORE BUT NOT USUALLY WHEN IT IS SO HOT OUTSIDE. I PUT IN ON AROUND 10 AM, AND THEN WENT WALKING. I PUT IT ON OVER MY UNDERGARMENTS AND UNDER A PAIR OF COTTON CAPRI PANTS. BY TIME 5:00 CAME, THE WRAP WAS TWISTED AND SOAKING WET AND MY BACK WAS BURNING. I TOOK OFF THE WRAP. WHEN WE GOT BACK TO THE HOTEL, I HAD MY HUSBAND LOOK AT MY BACK; I HAD 5 ROUND BURN MARKS ACROSS THE LOWER MID-BACK. I DID OF COURSE USE THE THERMACARE AGAIN. WHEN I GOT HOME A FEW DAYS LATER, I WENT TO MY FAMILY DOCTOR FOR THE PAIN AND BECAUSE THE BURNS WERE NOT HEALING. HE SAID 2 OF THE BURNS WERE 2ND DEGREE, AND 3 WERE 1ST DEGREE. HE USED A CLEANING SOLUTION THEN PUT A CREAM ON THE BURNS. HE WROTE ME A PRESCRIPTION FOR THE BURNS WHICH I USED FOR A COUPLE OF WEEKS. I STILL HAVE A COUPLE OF SCARS AFTER ALL THESE MONTHS. I REGRET I DID NOT MAKE MY COMPLAINT WHEN THIS HAPPENED. I HOPE THIS COMPLAINT NOW WILL PROVOKE SOME KIND OF STATEMENT, SO THAT OTHERS DO NOT HAVE THIS EVENT. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: LOWER BACK PAIN." } ], "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": "" } ] }