{ "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": "2026-06-30", "results": { "skip": 0, "limit": 1, "total": 2 } }, "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": "Other", "report_number": "3015729-2012-00003", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20121001", "manufacturer_address_2": "", "pma_pmn_number": "K032756", "date_of_event": "20120907", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "RISK MANAGER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Foreign", "Health Professional", "Company representation", "Distributor" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20121105", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20121001", "brand_name": "A-DEC 511 DENTAL CHAIR", "generic_name": "DENTAL CHAIR", "manufacturer_d_name": "A-DEC, INC.", "manufacturer_d_address_1": "2601 CRESTVIEW DR.", "manufacturer_d_address_2": "", "manufacturer_d_city": "NEWBERG", "manufacturer_d_state": "OR", "manufacturer_d_zip_code": "97132", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "97132", "device_operator": "HEALTH PROFESSIONAL", "model_number": "511", "catalog_number": "62.0641.00", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "EIA", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Unit, Operative Dental", "medical_specialty_description": "Dental", "regulation_number": "872.6640", "device_class": "1" } } ], "product_problems": [ "Break", "Device Operates Differently Than Expected" ], "reporter_state_code": "OR", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20121001", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Crushing Injury" ] } ], "distributor_city": "", "date_report": "20120920", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2799694", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120914", "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": "21945436", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "FOLLOW-UP INFORMATION FROM A-DEC (B)(4), (B)(4) 2012: MY FORENSIC INVESTIGATIONS HAVE REVEALED THAT THE STOP PLATE COVER (LOWER LIFT ARM) HAS RECEIVED A SIGNIFICANT HIT/IMPACT, ON THE TOP LHS. THIS IS ALSO CONSISTENT WITH THE FACT THAT THE TUBING ON THE UNDERSIDE OF THE LOWER SUPPORT ARM, WAS ALSO DISLODGED (ACCORDING TO THE TECHNICIAN), FROM THE SAFETY LIMIT SWITCH UNDER THE SUPPORT LINK. IT SEEMS THAT THE IMPACT HAS DISLODGED THE STOP PLATE COVER (LOWER LIFT ARM) SIDEWAYS, BROKEN THE STOP SWITCH ASSEMBLY (PADDLE) ON THE RHS, AND IT HAS FALLEN DOWN ON THE INSIDE OF THE COVER AND LEFT THERE HANGING LOOSE. THE GOVERNMENT SERVICE TECHNICIAN WAS QUICK TO RECONNECT THE TUBING, GLUE THE PADDLE (STOP SWITCH ASSEMBLY) BACK TOGETHER AND REPOSITION THE DISLODGED ASSEMBLY AND SWITCH. THE SENIOR DENTIST (DR (B)(6)) HAS SAID THAT THEY TREAT BARIATRIC PATIENTS, WHO SOMETIMES NEED TO BE LIFTED INTO THE CHAIR WITH SOME BULKY MECHANISM, WHICH NEEDS TO BE BROUGHT INTO THE ROOM, AND IT COULD HAVE KNOCKED THE CHAIR AND CAUSED THE DAMAGE. WE ARE NOW WAITING FOR AN ORDER FOR THE PARTS FROM THE GOVERNMENT, SO WE CAN FIX IT PROPERLY AND HOPEFULLY QUICKLY, BECAUSE THIS IS A SINGLE CHAIR CLINIC THAT IS CURRENTLY SHUT DOWN." }, { "mdr_text_key": "21988146", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AT 3PM OF (B)(6) 2012, DR. (B)(6) CAUGHT HER LEFT FOOT UNDER A DESCENDING 511 CHAIR THAT SHE WAS CONTROLLING WITH THE TOUCHPAD, RESULTING IN A BROKEN BONE. DR (B)(6) WAS LYING THE PATIENT BACK INTO THE SUPINE POSITION TO BEGIN TREATMENT, WHILE SITTING ALONGSIDE THE PATIENT. WHEN SHE REALIZED THAT HER FOOT WAS BEING CRUSHED, SHE ATTEMPTED TO STOP THE CHAIR BY PUSHING THE UP ARROW ON THE TOUCHPAD, BUT SHE WAS TOO LATE TO AVOID INJURY. SHE PULLED HER FOOT OUT, WITH THE ASSISTANCE OF THE DA AND PROCEEDED TO PLACE A TEMPORARY FILLING FOR THE PATIENT, BEFORE SEEKING ASSISTANCE HERSELF. DR. (B)(6) HAS BEEN PRACTICING FOR 12 YEARS, AND AT THIS CLINIC FOR 4 MONTHS. I WAS CONTACTED ABOUT THE INCIDENT ON (B)(4) AND ATTENDED A MEETING TO INSPECT THE CHAIR THE FOLLOWING DAY, WITH DR (B)(6) (DENTIST IN CHARGE) AND (B)(6) (BIOMEDICAL ENGINEER). UPON INSPECTION, IT BECAME CLEAR THAT THE SAFETY STOPPING PLATE WAS NOT WORKING, AND THE PADDLE ATTACHED TO THE SWITCH HAD BEEN BROKEN OFF. IT IS NOT CLEAR IF THIS DAMAGE OCCURRED BEFORE OR AFTER THE INCIDENT. THE CHAIR WAS 'CHECKED' BY A BIOMEDICAL ENGINEER IN JANUARY 2012. CHAIR HAS BEEN REMOVED FROM SERVICE UNTIL REPAIR CAN BE COMPLETED." } ], "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": "" } ] }