{ "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": 300898 } }, "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": "Injury", "report_number": "2518422-2008-00004", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080221", "manufacturer_address_2": "", "pma_pmn_number": "K954207", "date_of_event": "20080122", "reprocessed_and_reused_flag": "N", "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": [ "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20080226", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080221", "brand_name": "S PROFILE LITE NASAL MASK/HGR-DOM", "generic_name": "VENTILATOR, NON-CONTINUOUS (RESPIRATOR)", "manufacturer_d_name": "RESPIRONICS, INC", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MURRYSVILLE", "manufacturer_d_state": "PA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "LAY USER/PATIENT", "model_number": "1004087", "catalog_number": "1004087", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "BZD", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "2518422" ], "fei_number": [ "2518422" ], "device_name": "Ventilator, Non-Continuous (Respirator)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5905", "device_class": "2" } } ], "product_problems": [ "Unknown (for use when the device problem is not known)" ], "reporter_state_code": "WA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250729", "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": "20080221", "sequence_number_treatment": [ "CPAP DEVICE", " PATIENT TUBING", " HEAD GEAR" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "40 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Other (for use when an appropriate patient code cannot be identified)" ] } ], "distributor_city": "", "date_report": "20080122", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1001549", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080122", "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": "802270", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A PT ALLEGED, THEIR UPPER TEETH BECAME MISALIGNED AS A RESULT OF RECEIVING APPROX TWO YEARS OF CPAP THERAPY THROUGH A NASAL CPAP MASK. THE CPAP THERAPY WAS PROVIDED THROUGH A NASAL CPAP MASK (SECURED TO THE PT BY A HEADGEAR ASSEMBLY) BY A CPAP DEVICE AND PT TUBING ( USED TO CONNECT THE MASK TO THE CPAP DEVICE). THE CPAP THERAPY WAS PRESCRIBED FOR THE TREATMENT OF SLEEP APNEA. THE MASK ASSOCIATED WITH THIS CLAIM HAS NOT BEEN RECEIVED BY THE MFR FOR INVESTIGATION. THE MFR COMPLETED REVIEWS OF THEIR COMPLAINT AND THE FSA MAUDE DATABASES FOR REPORTS OF SIMILAR ISSUES. NO REPORTS OF NASAL CPAP MASK USE CAUSING OR CONTRIBUTING TO THE MISALIGNMENT OF PT TEETH WERE IDENTIFIED IN EITHER DATABASE. A THIRD PARTY HAS BEEN COMMISSIONED BY THE MFR TO EVALUATE THE REPORTED CLAIM. THE MFR WILL FILE AN MDR FOLLOW-UP REPORT WHEN THEIR INVESTIGATION IS COMPLETE." }, { "mdr_text_key": "8091210", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE NASAL CPAP MASK WAS NOT RETURNED TO THE MFR FOR INVESTIGATION." } ], "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": "" } ] }