-
Notifications
You must be signed in to change notification settings - Fork 1
/
Copy pathexample_entry.json
158 lines (158 loc) · 5.9 KB
/
example_entry.json
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
{
"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": "2017-05-05",
"results": {
"skip": 0,
"limit": 1,
"total": 1541064
}
},
"results": [
{
"manufacturer_contact_zip_ext": "",
"manufacturer_g1_address_2": "",
"event_location": "",
"report_to_fda": "Y",
"manufacturer_contact_t_name": "",
"manufacturer_contact_state": "",
"manufacturer_link_flag": "Y",
"manufacturer_g1_city": "ZUG",
"manufacturer_contact_address_2": "",
"event_type": "Malfunction",
"manufacturer_contact_pcity": "",
"manufacturer_contact_address_1": "GUBELSTRASSE 34",
"report_number": "3008382007-2012-09245",
"type_of_report": [
"Initial submission"
],
"product_problem_flag": "Y",
"date_received": "20130101",
"manufacturer_address_2": "",
"reprocessed_and_reused_flag": "N",
"manufacturer_address_1": "",
"manufacturer_contact_zip_code": "6300",
"manufacturer_contact_plocal": "",
"reporter_occupation_code": "PATIENT",
"manufacturer_contact_l_name": "WANDOLSKI",
"source_type": [
"Consumer"
],
"distributor_zip_code_ext": "",
"manufacturer_g1_postal_code": "6300",
"manufacturer_g1_state": "",
"date_facility_aware": "20121210",
"manufacturer_contact_area_code": "",
"manufacturer_contact_f_name": "YANNICK",
"previous_use_code": "I",
"device": [
{
"manufacturer_d_address_1": "GUBELSTRASSE 34",
"manufacturer_d_address_2": "",
"device_event_key": "",
"device_sequence_number": " 1.0",
"manufacturer_d_state": "",
"manufacturer_d_zip_code": "6300",
"manufacturer_d_city": "ZUG",
"lot_number": "3180296",
"manufacturer_d_postal_code": "6300",
"manufacturer_d_zip_code_ext": "",
"model_number": "",
"date_received": "20130101",
"device_report_product_code": "NBW",
"device_operator": "LAY USER/PATIENT",
"device_availability": "No",
"other_id_number": "",
"generic_name": "GLUCOSE MONITORING SYS/KIT",
"manufacturer_d_name": "LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL",
"manufacturer_d_country": "SZ",
"brand_name": "OT ULTRALINK METER",
"openfda": {
"device_name": "System, Test, Blood Glucose, Over The Counter",
"medical_specialty_description": "Clinical Chemistry",
"device_class": "2",
"regulation_number": "862.1345"
},
"device_age_text": "",
"device_evaluated_by_manufacturer": "R",
"catalog_number": "",
"implant_flag": "",
"date_removed_flag": ""
}
],
"manufacturer_zip_code": "",
"manufacturer_contact_country": "SZ",
"health_professional": "N",
"manufacturer_g1_zip_code_ext": "",
"manufacturer_city": "",
"manufacturer_contact_extension": "",
"manufacturer_contact_phone_number": "",
"patient": [
{
"sequence_number_treatment": [
""
],
"patient_sequence_number": "1",
"date_received": "20130101",
"sequence_number_outcome": [
""
]
},
{
"sequence_number_treatment": [
""
],
"patient_sequence_number": "1",
"date_received": "20130101",
"sequence_number_outcome": [
""
]
}
],
"distributor_city": "",
"distributor_state": "",
"date_report": "20121210",
"initial_report_to_fda": "Unknown",
"manufacturer_g1_country": "SZ",
"event_key": "",
"manufacturer_contact_city": "ZUG",
"mdr_report_key": "2891923",
"removal_correction_number": "",
"number_devices_in_event": "",
"date_manufacturer_received": "20121210",
"manufacturer_name": "",
"report_source_code": "Manufacturer report",
"remedial_action": [
""
],
"manufacturer_g1_zip_code": "6300",
"manufacturer_zip_code_ext": "",
"report_to_manufacturer": "",
"manufacturer_g1_name": "LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL",
"distributor_address_1": "",
"adverse_event_flag": "N",
"manufacturer_state": "",
"distributor_address_2": "",
"manufacturer_postal_code": "",
"manufacturer_country": "",
"single_use_flag": "N",
"mdr_text": [
{
"mdr_text_key": "16750885",
"text_type_code": "Description of Event or Problem",
"patient_sequence_number": "1",
"text": "ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) IN USA ALLEGING AN ER 2 ISSUE. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY DUE TO THE ALLEGED ISSUE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE REMAINED UNRESOLVED."
}
],
"number_patients_in_event": "",
"distributor_name": "",
"manufacturer_g1_address_1": "GUBELSTRASSE 34",
"distributor_zip_code": "",
"manufacturer_contact_exchange": "",
"manufacturer_contact_postal_code": "6300",
"manufacturer_contact_pcountry": ""
}
]
}