{ "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": 171 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "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": "Malfunction", "report_number": "2515379-2008-00027", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20080408", "manufacturer_address_2": "", "pma_pmn_number": "K031615", "date_of_event": "20080307", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "DENTIST", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "AS", "manufacturer_contact_area_code": "", "date_added": "20090317", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080408", "brand_name": "SMARTLITE IQ 2", "generic_name": "", "manufacturer_d_name": "DENTSPLY CAULK", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MILFORD", "manufacturer_d_state": "DE", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "NA", "catalog_number": "644026", "lot_number": "060410", "other_id_number": "NA", "device_availability": "Yes", "date_returned_to_manufacturer": "20080404", "device_report_product_code": "EBZ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "2515379" ], "fei_number": [ "2515379" ], "device_name": "Activator, Ultraviolet, For Polymerization", "medical_specialty_description": "Dental", "regulation_number": "872.6070", "device_class": "2" } } ], "product_problems": [ "Unknown (for use when the device problem is not known)" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20080408", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "UNK", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Electric Shock" ] } ], "distributor_city": "", "date_report": "20080310", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1026039", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080310", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "17257950", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT A MEMBER OF THE OFFICE STAFF RECEIVED AN ELECTRIC SHOCK WHILE HOLDING A SMARTLIGHT IQ2 CHARGER AND HANDPIECE, AND CONTACTING A PIECE OF METAL ON THE WALL. NO INJURY RESULTED." }, { "mdr_text_key": "17284688", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE UNIT IN QUESTION MAY HAVE CAUSED THE SENSATION OR IT MAY HAVE BEEN THE RESULT OF STATIC DISCHARGE OR OTHER FACTORS. THOUGH, THERE WAS NO REPORT OF INJURY, BECAUSE DEVICE EVALUATION RESULTS ARE NOT AVAILABLE AT THIS TIME, THIS INCIDENT WOULD BE CONSIDERED A MALFUNCTION WHICH, IF IT WERE TO RECUR, COULD POSSIBLY RESULT IN PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR FUNCTION OR RESULT IN AN INJURY REQUIRING MEDICAL INTERVENTION TO PRECLUDE SUCH, PARTICULARLY IN INDIVIDUALS WITH PACEMAKERS. THE DEVICE WAS RETURNED TO THE PHYSICAL MANUFACTURER FOR EVALUATION, THOUGH, RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE." } ], "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": "" } ] }