{ "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": 325 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "9612330-2020-00004", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200501", "manufacturer_address_2": "", "pma_pmn_number": "UNKNOWN", "date_of_event": "20190925", "reprocessed_and_reused_flag": "I", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200501", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "483064", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200501", "brand_name": "EEG", "generic_name": "EEG", "manufacturer_d_name": "NATUS MEDICAL INCORPORATED", "manufacturer_d_address_1": "2568 BRISTOL CIRCLE", "manufacturer_d_address_2": "OAKVILLE", "manufacturer_d_city": "ONTARIO,", "manufacturer_d_state": "", "manufacturer_d_zip_code": "L6H 5", "manufacturer_d_zip_code_ext": "S1", "manufacturer_d_country": "CA", "manufacturer_d_postal_code": "L6H 5S1", "device_operator": "I", "model_number": "UNKNOWN", "catalog_number": "UNKNOWN", "lot_number": "", "other_id_number": "", "device_availability": "No answer provided", "device_report_product_code": "GWQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Full-Montage Standard Electroencephalograph", "medical_specialty_description": "Neurology", "regulation_number": "882.1400", "device_class": "2", "registration_number": [ "9612330" ], "fei_number": [ "3002809369" ] } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*;*", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20200501", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn, Thermal", "Lead(s), Burn(s) From", "Burn, Thermal", "Lead(s), Burn(s) From" ] } ], "distributor_city": "", "date_report": "20190925", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10016671", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Manufacturer 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": "319984374", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATE 27TH AUGUST 2020. INVESTIGATION RESULTS & FINDINGS (NATUS COMPLAINT REF. # (B)(4)). NO PRODUCT WAS RETURNED FOR THIS EVALUATION. SINCE THE TIME OF THE LAST UPDATE TO THIS RECORD, FURTHER INVESTIGATION OF NATUS SALES RECORDS INDICATED THAT THERE IS NO RECORD ON FILE SHOWING THAT (B)(6) HEALTHCARE PURCHASED LEAD ELECTRODES FROM NATUS. DUE TO THE FACT THAT IT WAS NOT POSSIBLE TO DETERMINE IF A NATUS DEVICE WAS INVOLVED WITH THIS INCIDENT, NATUS SHOULD NOT HAVE SUBMITTED THIS MEDWATCH REPORT TO THE FDA." }, { "mdr_text_key": "319984375", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "EVIDENCE OF BURN WOUNDS ON PATIENT POST EEG." }, { "mdr_text_key": "318223639", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATE (B)(6) 2020 (NATUS COMPLAINT REF. #(B)(4)). BASED ON THE RISK ASSESSMENT FILE, THE RISK IS LOW. THERE IS NO FURTHER INFORMATION ABOUT THE EVENT DESPITE NUMEROUS REQUESTS FOR UPDATES FROM THE CUSTOMER." }, { "mdr_text_key": "318223640", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON THE (B)(6) 2019, A GIRL WAS ADMITTED TO HOSPITAL AND AN EEG WAS ORDERED BY DR. ERIC ANDERSON. THE EEG WAS PERFORMED BY (B)(6) PERLINSKI. WHEN THE TEST WAS DONE, KATHRYN NOTED IN HER REPORT NO ADVERSE SKIN EVENTS. HOWEVER, THE GIRL WAS LATER HOSPITALIZED TO TREAT THE BURN WOUNDS UNTIL 6-2-19. THE GIRL STILL HAS VISIBLE WOUNDS ON HER FOREHEAD, AND ON THE BACK OF HER SKULL. SHE DESCRIBES THEM AS INDENTED AND SCABBING." }, { "mdr_text_key": "200613114", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INVESTIGATION RESULTS & FINDINGS (NATUS COMPLAINT REF. # (B)(4)). NO PRODUCT HAS BEEN RETURNED TO DATE FOR EVALUATION. TWO ATTEMPTS HAVE BEEN MADE IN AN EFFORT TO OBTAIN MORE INFORMATION ON THE SUSPECT PRODUCT CONCERNED WITH THIS DEVICE BUT TO NO AVAIL TO DATE. A FURTHER ATTEMPT WILL BE MADE IN AN EFFORT TO OBTAIN ADDITIONAL INFORMATION." }, { "mdr_text_key": "200613115", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON THE (B)(6) 2019, A GIRL WAS ADMITTED TO HOSPITAL AND AN EEG WAS ORDERED BY DR. (B)(6). THE EEG WAS PERFORMED BY (B)(6). WHEN THE TEST WAS DONE, (B)(6) NOTED IN HER REPORT NO ADVERSE SKIN EVENTS. HOWEVER, THE GIRL WAS LATER HOSPITALIZED TO TREAT THE BURN WOUNDS UNTIL (B)(6) 2019. THE GIRL STILL HAS VISIBLE WOUNDS ON HER FOREHEAD, AND ON THE BACK OF HER SKULL. SHE DESCRIBES THEM AS INDENTED AND SCABBING." } ], "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": "06/01/2020;08/27/2020" } ] }