{ "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": 3163 } }, "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": "3011175548-2020-00583", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "ES", "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": "463327", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "OCEAN CHEST DRAIN", "generic_name": "APPARATUS, AUTOTRANSFUSION", "manufacturer_d_name": "ATRIUM MEDICAL CORPORATION", "manufacturer_d_address_1": "40 CONTINENTAL BLVD", "manufacturer_d_address_2": "", "manufacturer_d_city": "MERRIMACK", "manufacturer_d_state": "NH", "manufacturer_d_zip_code": "03054", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "03054", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "CAC", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "3011175548" ], "fei_number": [ "3011175548" ], "device_name": "Apparatus, Autotransfusion", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5830", "device_class": "2" } } ], "product_problems": [ "Gas/Air Leak" ], "reporter_state_code": "", "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": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Information", "No Information" ] } ], "distributor_city": "", "date_report": "20200427", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000776", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200422", "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": "190478748", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "WE ARE UNABLE TO FULLY INVESTIGATE THIS REPORT AS NO PRODUCT NUMBER, LOT NUMBER OR SAMPLE WAS PROVIDED. IT IS NOT KNOWN WHAT RELATIONSHIP THE OCEAN CHEST DRAIN HAS TO THE REPORTED ADVERSE EVENTS. THE ARTICLE CONCLUDED THE DIGITAL THORACIC DRAINAGE SYSTEMS PROVIDE AN OBJECTIVE MEASUREMENT OF AIR LEAKAGE, ALLOWING EARLY CHEST TUBE REMOVAL AND DECREASING THE NUMBER OF RADIOGRAPHS PERFORMED POSTOPERATIVELY. ITS USE IN THE PEDIATRIC POPULATION APPEARS TO BE SAFE AND POTENTIALLY BENEFICIAL. BASED ON THE INFORMATION AVAILABLE ATRIUM HAS DETERMINED THAT THE EVENTS DESCRIBED ARE NOT RELATED TO A PRODUCT FAILURE." }, { "mdr_text_key": "190478749", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "RECEIVED AN ARTICLE TITLED DIGITAL THORACIC DRAINAGE: A NEW SYSTEM TO MONITOR AIR LEAKS IN PEDIATRIC POPULATION. PURPOSE: THE OBJECTIVE OF OUR STUDY IS TO ANALYZE THEIR SAFETY AND EFFECTIVENESS IN THE POSTOPERATIVE PERIOD OF THE PEDIATRIC PATIENTS. METHOD: A PROSPECTIVE CONSECUTIVE OBSERVATIONAL STUDY WAS DONE. ALL PATIENTS SUBMITTED TO PULMONARY RESECTION BETWEEN 2011 AND 2017 AND IN WHOM DIGITAL THORACIC DRAINAGE SYSTEM WAS USED WERE PROSPECTIVELY ENROLLED IN THIS STUDY. PER THE ARTICLE ADVERSE EVENTS INCLUDED: PERSISTENT AIR LEAKAGE REQUIRING BLOOD PLEURODESIS." } ], "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": "" } ] }