_dta: 1. mdrfoithru2015 set up by Jean Roth , jroth@nber.org , 27 Jan 2017 2. MAUDE Master Record through 2015 3. SECTION-E (if source code is 'P', Section E to H will contain no data) 4. SECTION-G (only for report source 'M', others sources will be null) distributor_name: 1. if report source code = 'M' and Manufacturer link flag is 'Y', fields 14 - 20 will contain data; 2. otherwise they will be null obs: 5,052,589 vars: 93 27 Jan 2017 14:22 size: 5,598,268,612 (_dta has notes) ---------------------------------------------------------------------------------------------------------------------------------------------------------------- storage display value variable name type format label variable label ---------------------------------------------------------------------------------------------------------------------------------------------------------------- mdr_report_key long %12.0g Medical Device Reporting (MDR) Report Key event_key byte %8.0g Event Key report_number str21 %21s Report Number report_source_code byte %20.0g report_source_code Report Source Code report_source_codestr str1 %9s Report Source Code manufacturer_link_flag str1 %9s Manufacturer Link Flag (internal information flag) number_devices_in_event byte %8.0g Number Devices in Event (if source code is 'P', field will be null) number_patients_in_event byte %8.0g Number Patient in Event (if source code is 'P', field will be null) date_received int %td Date Received date_receivedstr str10 %10s Date Received adverse_event_flag str1 %9s Adverse Event Flag (B1) product_problem_flag str1 %9s Product Problem Flag (B1) date_report int %td Date Report (B4) date_reportstr str10 %10s Date Report (B4) date_of_event int %td Date of Event (B3) -- new added, 2006 date_of_eventstr str10 %10s Date of Event (B3) -- new added, 2006 reprocessed_and_reused_flag str1 %9s Single Use Flag (Reprocessor Flag) (D8) -- new added, 2006 reporter_occupation_cod int %51.0g rep_occ_code Reporter Occupation Code (E3) -- new added, 2006 reporter_occupation_codestr str3 %9s Reporter Occupation Code (E3) -- new added, 2006 health_professional str1 %9s Health Professional (E2) initial_report_to_fda str1 %9s Initial Report to FDA (E4) date_facility_aware byte %td Date Facility Aware (F6) date_facility_awarestr str23 %23s Date Facility Aware (F6) report_date int %td 26. Report Date (F8) report_datestr str10 %10s 26. Report Date (F8) report_to_fda str1 %9s Report to FDA (F11) date_report_to_fda int %td Date Report to FDA (F11) date_report_to_fdastr str10 %10s Date Report to FDA (F11) event_location int %35.0g event_location Event Location (F12) date_report_to_manufacturer int %td Date Report to Manufacturer (F13) date_report_to_manufacturerstr str10 %10s Date Report to Manufacturer (F13) manufacturer_contact_t_name str4 %9s Manufacturer Contact Title Name (G1) manufacturer_contact_f_name str15 %15s Manufacturer Contact First Name (G1) manufacturer_contact_l_name str25 %25s Manufacturer Contact Last Name (G1) manufacturer_contact_street_1 str60 %60s MANUFACTURER_CONTACT_STREET_1 manufacturer_contact_street_2 str220 %220s MANUFACTURER_CONTACT_STREET_2 manufacturer_contact_city str40 %40s MANUFACTURER_CONTACT_CITY manufacturer_contact_state str2 %9s MANUFACTURER_CONTACT_STATE manufacturer_contact_zip_code str5 %9s MANUFACTURER_CONTACT_ZIP_CODE manufacturer_contact_zip_ext str4 %9s MANUFACTURER_CONTACT_ZIP_EXT manufacturer_contact_country str2 %9s MANUFACTURER_CONTACT_COUNTRY manufacturer_contact_postal str10 %10s MANUFACTURER_CONTACT_POSTAL manufacturer_contact_area_code str3 %9s Manufacturer Contact Phone No Area Code (G1) manufacturer_contact_exchange str3 %9s MANUFACTURER_CONTACT_EXCHANGE manufacturer_contact_phone_no str4 %9s Manufacturer Contact Phone No (G2) manufacturer_contact_extension str5 %9s Manufacturer Contact Phone No Ext (G2) manufacturer_contact_pcountry str3 %9s Manufacturer Contact Phone No Country Code manufacturer_contact_pcity str8 %9s Manufacturer Contact Phone No City Code manufacturer_contact_plocal str10 %10s Manufacturer Contact Phone No Local manufacturer_g1_name str184 %184s Manufacturer G1 Name (G1) manufacturer_g1_street_1 str60 %60s Manufacturer G1 Street 1 (G1) manufacturer_g1_street_2 str50 %50s Manufacturer G1 Street 2 (G1) manufacturer_g1_city str40 %40s Manufacturer G1 City (G1) manufacturer_g1_state_code str2 %9s Manufacturer G1 State Code (G1) manufacturer_g1_zip_code str5 %9s Manufacturer G1 Zip Code (G1) manufacturer_g1_zip_code_ext str4 %9s Manufacturer G1 Zip Code Ext (G1) manufacturer_g1_country_code str2 %9s Manufacturer G1 Country Code manufacturer_g1_postal_code str10 %10s Manufacturer G1 Postal Code date_manufacturer_received int %td Date Manufacturer Received (G4) date_manufacturer_receivedstr str10 %10s Date Manufacturer Received (G4) device_date_of_manufacture int %td Device Date Of Manufacture (H4) device_date_of_manufacturestr str10 %10s Device Date Of Manufacture (H4) single_use_flag str1 %9s Single Use Flag (H5) remedial_action int %23.0g remedial_action Remedial Action (H7) -- multiple source type, separate by ',' remedial_actionstr str2 %9s Remedial Action (H7) -- multiple source type, separate by ',' previous_use_code str1 %9s Previous Use Code (H8) removal_correction_number str72 %72s Removal/Correction Number (H9) event_type int %11.0g event_type Event type (H1) -- only relevant for report source_type 'M' event_typestr str2 %9s Event type (H1) -- only relevant for report source_type 'M' distributor_name byte %8.0g * Distributor Name (F3) distributor_address_1 byte %8.0g Distributor Address line 1 (F3) distributor_address_2 byte %8.0g Distributor Address line 2 (F3) distributor_city byte %8.0g Distributor City (F3) distributor_state_code byte %8.0g Distributor State Code (F3) distributor_zip_code byte %8.0g Distributor Zip Code (F3) distributor_zip_code_ext str1 %9s Distributor Zip Code Ext (F3) report_to_manufacturer byte %8.0g Report to Manufacturer (F13) manufacturer_name byte %8.0g Manufacturer Name (F14) manufacturer_address_1 byte %8.0g Manufacturer Address line 1 (F14) manufacturer_address_2 byte %8.0g Manufacturer Address line 2 (F14) manufacturer_city byte %8.0g Manufacturer City (F14) manufacturer_state_code byte %8.0g Manufacturer State Code (F14) manufacturer_zip_code byte %8.0g Manufacturer Zip Code (F14) manufacturer_zip_code_ext str1 %9s Manufacturer Zip Code Ext (F14) manufacturer_country_code byte %8.0g Manufacturer Country Code (F14) manufacturer_postal_code byte %8.0g Manufacturer Postal Code (F14) type_of_report int %32.0g type_of_report Type of Report (F7) type_of_reportstr str9 %9s Type of Report (F7) source_type int %51.0g source_type Source Type (G3) -- multiple source type, separate by ',' source_typestr str29 %29s Source Type (G3) -- multiple source type, separate by ',' date_added str10 %10s DATE_ADDED date_changed str10 %10s DATE_CHANGED event_locationstr str3 %9s Event Location (F12) * indicated variables have notes ---------------------------------------------------------------------------------------------------------------------------------------------------------------- Sorted by: mdr_report_key Note: Dataset has changed since last saved. report_source_code: 4 Distributor report 13 Manufacturer report 16 Voluntary report 21 User Facility report rep_occ_code: -4 UNKNOWN -3 NO INFORMATION -2 NOT APPLICABLE -1 INVALID DATA 0 OTHER 1 PHYSICIAN 2 NURSE 8 HEALTH PROFESSIONAL 12 LAY USER/PATIENT 100 OTHER HEALTH CARE PROFESSIONAL 101 AUDIOLOGIST 102 DENTAL HYGIENIST 103 DIETICIAN 104 EMERGENCY MEDICAL TECHNICIAN 105 MEDICAL TECHNOLOGIST 106 NUCLEAR MEDICINE TECHNOLOGIST 107 OCCUPATIONAL THERAPIST 108 PARAMEDIC 109 PHARMACIST 110 PHLEBOTOMIST 111 PHYSICAL THERAPIST 112 PHYSICIAN ASSISTANT 113 RADIOLOGIC TECHNOLOGIST 114 RESPIRATORY THERAPIST 115 SPEECH THERAPIST 116 DENTIST 300 OTHER CAREGIVERS 301 DENTAL ASSISTANT 302 HOME HEALTH AIDE 303 MEDICAL ASSISTANT 304 NURSING ASSISTANT 305 PATIENT 306 PATIENT FAMILY MEMBER OR FRIEND 307 PERSONAL CARE ASSISTANT 400 SERVICE AND TESTING PERSONNEL 401 BIOMEDICAL ENGINEER 402 HOSPITAL SERVICE TECHNICIAN 403 MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE 404 PHYSICIST 405 SERVICE PERSONNEL 499 DEVICE UNATTENDED 500 RISK MANAGER 600 ATTORNEY 999 UNKNOWN event_location: -4 UNKNOWN -3 NO INFORMATION -2 NOT APPLICABLE -1 INVALID DATA 0 OTHER 1 HOSPITAL 2 HOME 3 NURSING HOME 4 OUTPATIENT TREATMENT FACILITY 5 OUTPATIENT DIAGNOSTIC FACILITY 6 AMBULATORY SURGICAL FACILITY 500 HOSPITAL 501 CATHETERIZATION SUITE 502 CRITICAL CARE UNIT 503 DIALYSIS UNIT 504 EMERGENCY ROOM 505 EXAMINATION ROOM 506 LABORATORY/PATHOLOGY DEPARTMENT 507 MATERNITY WARD - NURSERY 508 OPERATING ROOM 509 OUTPATIENT CLINIC/SURGERY 510 PATIENT'S ROOM OR WARD 511 RADIOLOGY DEPARTMENT 600 AMBULATORY HEALTH CARE FACILITY 601 AMBULATORY SURGICAL CENTER 602 BLOOD BANK 603 BLOODMOBILE 604 CATHETERIZATION LAB - FREE STANDING 605 CHEMOTHERAPY CENTER 606 CLINIC - WALK IN, OTHER 607 DIALYSIS CENTER 608 DRUG CLINIC 609 IMAGING CENTER - MOBILE 610 IMAGING CENTER - STATIONARY 611 LABORATORY 612 MOBILE HEALTH UNIT 613 MRI CENTERS 614 PSYCHIATRIC CENTER - WALK IN, OTHER 615 TUBERCULOSIS CLINIC 616 URGENT CARE CENTER 617 OUTPATIENT DIAGNOSTIC FACILITY 700 LONG-TERM CARE FACILITY 701 HOSPICE 702 NURSING HOME 703 PSYCHIATRIC FACILITY 704 REHABILITATION CENTER 705 RETIREMENT HOME 810 PATIENT'S HOME 820 IN TRANSIT TO USER/MEDICAL FACILITY 830 PUBLIC VENUE 831 OUTDOORS 832 PARK 833 PLAYGROUND 834 PUBLIC BUILDING 835 SCHOOL 836 STREET 999 UNKNOWN remedial_action: 914 Inspection 1301 Modification/Adjustment 1415 Notification 1520 Other 1613 Patient Monitoring 1802 Relabeling 1803 Recall 1812 Replace 1816 Repair event_type: 4 Death 13 Malfunction 15 Other 910 Injury 912 Injury 914 Injury type_of_report: 6 F = Followup 9 Initial submission 15 O = Other information submitted 24 X = Extra copy received 606 Followup, Followup 609 F = Followup, Initial Submission 906 Initial submission, Followup source_type: 0 00 Other 1 01 Foreign 2 02 Study 3 03 Literature 4 04 Consumer 5 05 Health Professional 6 06 User facility 7 07 Company representation 8 08 Distributor 99 99 Unknown 100 01 Foreign,00 Other 101 01 Foreign,01 Foreign 102 01 Foreign,02 Study 103 01 Foreign,03 Literature 104 01 Foreign,04 Consumer 105 01 Foreign,05 Health Professional 106 01 Foreign,06 User facility 107 01 Foreign,07 Company representation 108 01 Foreign,08 Distributor 199 01 Foreign,99 Unknown 200 02 Study,00 Other 201 02 Study,01 Foreign 202 02 Study,02 Study 203 02 Study,03 Literature 204 02 Study,04 Consumer 205 02 Study,05 Health Professional 206 02 Study,06 User facility 207 02 Study,07 Company representation 208 02 Study,08 Distributor 299 02 Study,99 Unknown 300 03 Literature,00 Other 301 03 Literature,01 Foreign 302 03 Literature,02 Study 303 03 Literature,03 Literature 304 03 Literature,04 Consumer 305 03 Literature,05 Health Professional 306 03 Literature,06 User facility 307 03 Literature,07 Company representation 308 03 Literature,08 Distributor 399 03 Literature,99 Unknown 400 04 Consumer,00 Other 401 04 Consumer,01 Foreign 402 04 Consumer,02 Study 403 04 Consumer,03 Literature 404 04 Consumer,04 Consumer 405 04 Consumer,05 Health Professional 406 04 Consumer,06 User facility 407 04 Consumer,07 Company representation 408 04 Consumer,08 Distributor 499 04 Consumer,99 Unknown 500 05 Health Professional,00 Other 501 05 Health Professional,01 Foreign 502 05 Health Professional,02 Study 503 05 Health Professional,03 Literature 504 05 Health Professional,04 Consumer 505 05 Health Professional,05 Health Professional 506 05 Health Professional,06 User facility 507 05 Health Professional,07 Company representation 508 05 Health Professional,08 Distributor 599 05 Health Professional,99 Unknown 600 06 User facility,00 Other 601 06 User facility,01 Foreign 602 06 User facility,02 Study 603 06 User facility,03 Literature 604 06 User facility,04 Consumer 605 06 User facility,05 Health Professional 606 06 User facility,06 User facility 607 06 User facility,07 Company representation 608 06 User facility,08 Distributor 699 06 User facility,99 Unknown 700 07 Company representation,00 Other 701 07 Company representation,01 Foreign 702 07 Company representation,02 Study 703 07 Company representation,03 Literature 704 07 Company representation,04 Consumer 705 07 Company representation,05 Health Professional 706 07 Company representation,06 User facility 707 07 Company representation,07 Company representation 708 07 Company representation,08 Distributor 799 07 Company representation,99 Unknown 800 08 Distributor,00 Other 801 08 Distributor,01 Foreign 802 08 Distributor,02 Study 803 08 Distributor,03 Literature 804 08 Distributor,04 Consumer 805 08 Distributor,05 Health Professional 806 08 Distributor,06 User facility 807 08 Distributor,07 Company representation 808 08 Distributor,08 Distributor 899 08 Distributor,99 Unknown 9900 99 Unknown,00 Other 9901 99 Unknown,01 Foreign 9902 99 Unknown,02 Study 9903 99 Unknown,03 Literature 9904 99 Unknown,04 Consumer 9905 99 Unknown,05 Health Professional 9906 99 Unknown,06 User facility 9907 99 Unknown,07 Company representation 9908 99 Unknown,08 Distributor 9999 99 Unknown,99 Unknown 10000 00 Other,00 Other 10001 00 Other,01 Foreign 10002 00 Other,02 Study 10003 00 Other,03 Literature 10004 00 Other,04 Consumer 10005 00 Other,05 Health Professional 10006 00 Other,06 User facility 10007 00 Other,07 Company representation 10008 00 Other,08 Distributor 10099 00 Other,99 Unknown