| Device Malfunction |
Other Serious |
|
|
Male |
|
11/10/2010 |
Consumer |
United States |
|
| Device Malfunction |
Other Serious |
|
|
Female |
|
11/10/2010 |
Consumer |
United States |
|
| Product Quality Issue |
Other Serious |
|
|
Male |
|
11/10/2010 |
Consumer |
United States |
|
| Device Malfunction |
Other Serious |
|
|
Male |
|
11/15/2010 |
Consumer |
United States |
|
| Device Malfunction |
Other Serious |
|
|
Male |
|
11/15/2010 |
Consumer |
United States |
|
| Device Malfunction |
Other Serious |
|
|
Male |
|
11/15/2010 |
Consumer |
United States |
|
| Device Malfunction |
Other Serious |
|
|
Female |
|
11/15/2010 |
Consumer |
United States |
|
| Device Malfunction |
Other Serious |
|
|
|
|
11/15/2010 |
Consumer |
United States |
|
| Product Quality Issue |
Other Serious |
|
|
Male |
|
11/15/2010 |
Consumer |
United States |
|
| Product Quality Issue |
Other Serious |
|
|
Male |
|
11/15/2010 |
Consumer |
Japan |
|
| Product Quality Issue |
Other Serious |
|
|
|
|
11/15/2010 |
Consumer |
Japan |
|
| Product Quality Issue |
Other Serious |
|
|
|
|
11/15/2010 |
Consumer |
Japan |
|
| Product Quality Issue |
Other Serious |
|
|
Female |
|
11/15/2010 |
Consumer |
United States |
|
| Product Quality Issue |
Other Serious |
|
|
Male |
|
11/15/2010 |
Consumer |
Japan |
|
| Device Malfunction |
Other Serious |
|
|
Male |
|
11/15/2010 |
Consumer |
Japan |
|
| Product Quality Issue |
Other Serious |
|
|
Female |
|
11/15/2010 |
Pharmacist |
United States |
|
| Product Quality Issue |
Other Serious |
|
|
Female |
|
11/15/2010 |
Consumer |
United States |
|
| Device Malfunction |
Other Serious |
|
|
|
|
11/15/2010 |
Pharmacist |
United States |
|
| Product Quality Issue |
Other Serious |
|
|
Female |
|
11/15/2010 |
Consumer |
United States |
|
| Product Quality Issue |
Other Serious |
|
|
Female |
|
11/15/2010 |
Consumer |
United States |
|
| Product Quality Issue |
Other Serious |
|
|
Male |
|
11/15/2010 |
Consumer |
United States |
|
| Product Quality Issue |
Other Serious |
|
|
|
|
11/15/2010 |
Consumer |
South Africa |
|
| Product Quality Issue |
Other Serious |
|
|
Male |
|
11/15/2010 |
Consumer |
United States |
|
| Product Quality Issue |
Other Serious |
|
|
Female |
|
11/15/2010 |
Consumer |
United States |
|
| Device Malfunction |
Other Serious |
|
|
Female |
|
11/15/2010 |
Pharmacist |
Canada |
|
| Device Malfunction |
Other Serious |
|
|
|
|
11/15/2010 |
Consumer |
Canada |
|
| Device Malfunction |
Other Serious |
|
|
Male |
|
11/15/2010 |
Consumer |
Canada |
|
| Device Malfunction |
Other Serious |
|
|
Female |
|
11/15/2010 |
Pharmacist |
Canada |
|
| Device Malfunction |
Other Serious |
|
|
Male |
|
11/17/2010 |
Consumer |
United States |
|
| Device Malfunction |
Other Serious |
|
|
Male |
|
11/17/2010 |
Consumer |
United States |
|
| Device Malfunction |
Other Serious |
|
|
Female |
|
11/17/2010 |
Consumer |
United States |
|
| Device Malfunction |
Other Serious |
|
|
Female |
|
11/17/2010 |
Consumer |
United States |
|
| Product Quality Issue |
Other Serious |
|
|
Female |
|
11/18/2010 |
Consumer |
United States |
|
| Vision Blurred |
Other Serious |
1/1/2009 |
50 |
Female |
130 lb |
11/19/2010 |
Consumer |
Brazil |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Decreased |
Other Serious |
11/1/2010 |
54 |
Male |
157 lb |
11/19/2010 |
Consumer |
Brazil |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Wrong Technique In Drug Usage Process |
Other Serious |
|
|
Male |
|
11/19/2010 |
Consumer |
United States |
|
| Wrong Drug Administered |
Other Serious |
9/17/2010 |
8 |
Female |
73 lb |
12/2/2010 |
Other Health Professional |
Saudi Arabia |
|
| Road Traffic Accident |
Other Serious |
3/3/2009 |
48 |
Female |
|
12/6/2010 |
Consumer |
Canada |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Device Malfunction |
Other Serious |
|
|
|
|
12/6/2010 |
Consumer |
United States |
|
| Device Malfunction |
Other Serious |
|
|
|
|
12/6/2010 |
Pharmacist |
Canada |
|
| Wrong Drug Administered |
Other Serious |
11/8/2010 |
56 |
Female |
375 lb |
12/6/2010 |
Physician |
Mexico |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Product Quality Issue |
Other Serious |
|
|
Male |
|
12/6/2010 |
Consumer |
United States |
|
| Death |
Death |
|
81 |
Female |
148 lb |
7/24/2012 |
Physician |
Germany |
|
| Blood Glucose Increased |
Other Serious |
1/1/2012 |
60 |
Female |
|
7/26/2012 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Other Serious |
1/1/2009 |
64 |
Female |
|
7/26/2012 |
Consumer |
United States |
|
| Renal Failure |
Hospitalization |
1/1/2012 |
|
Female |
|
7/26/2012 |
Consumer |
United States |
|
| Dyspnoea |
Hospitalization |
7/16/2012 |
48 |
Female |
|
7/31/2012 |
Consumer |
South Africa |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Blindness Unilateral |
Other Serious |
|
|
Female |
|
7/31/2012 |
Consumer |
United States |
|
| Malaise |
Hospitalization |
5/27/2012 |
62 |
Female |
|
7/30/2012 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Spinal Column Stenosis |
Other Serious |
3/1/2012 |
79 |
Male |
|
7/30/2012 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Impaired Healing |
Other Serious |
1/1/2012 |
|
Female |
|
7/30/2012 |
Consumer |
United States |
|
| Hyperhidrosis |
Other Serious |
2/11/2012 |
47 |
Male |
208 lb |
7/31/2012 |
Pharmacist |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Syncope |
Other Serious |
|
|
Male |
|
8/1/2012 |
Pharmacist |
Netherlands |
|
| Micturition Urgency |
Other Serious |
12/1/2010 |
70 |
Male |
143 lb |
8/3/2012 |
Consumer |
Brazil |
|
| Convulsion |
Hospitalization |
6/26/2011 |
36 |
Male |
|
8/3/2012 |
Other Health Professional |
Japan |
|
| Hypotension |
Other Serious |
7/17/2012 |
68 |
Male |
165 lb |
8/6/2012 |
Consumer |
Brazil |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Chest Pain |
Other Serious |
7/1/2012 |
49 |
Female |
|
8/7/2012 |
Consumer |
United States |
|
| Device Malfunction |
Hospitalization |
7/30/2012 |
64 |
Female |
|
8/7/2012 |
Consumer |
United States |
|
| Hyperhidrosis |
Other Serious |
7/1/2012 |
90 |
Female |
|
8/7/2012 |
Consumer |
Greece |
|
| Hypoaesthesia |
Hospitalization |
|
49 |
Female |
|
8/9/2012 |
Consumer |
United States |
|
| Idiopathic Thrombocytopenic Purpura |
Other Serious |
|
90 |
Female |
|
8/10/2012 |
Physician |
Argentina |
|
| Renal Failure Chronic |
Other Serious |
3/29/2011 |
63 |
Female |
117 lb |
8/10/2012 |
Physician |
Japan |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Gastric Ulcer |
Hospitalization |
7/23/2012 |
47 |
Female |
|
8/13/2012 |
Consumer |
South Africa |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Feeling Abnormal |
Other Serious |
1/1/2010 |
77 |
Female |
137 lb |
8/13/2012 |
Consumer |
Brazil |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Disorientation |
Hospitalization |
8/3/2012 |
72 |
Male |
|
8/13/2012 |
Consumer |
South Africa |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Visual Acuity Reduced |
Hospitalization |
1/1/2011 |
74 |
Male |
172 lb |
8/13/2012 |
Consumer |
Brazil |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Blood Glucose Increased |
Other Serious |
12/9/2011 |
|
Female |
|
8/13/2012 |
Consumer |
China |
|
| Renal Disorder |
Hospitalization |
1/1/2008 |
60 |
Male |
168 lb |
8/13/2012 |
Consumer |
Brazil |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Gastrointestinal Infection |
Hospitalization |
7/30/2012 |
36 |
Female |
|
8/13/2012 |
Consumer |
South Africa |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Injection Site Pain |
Hospitalization |
|
64 |
Female |
|
8/14/2012 |
Consumer |
United States |
|
| Death |
Death |
|
|
Male |
|
8/15/2012 |
Consumer |
United States |
|
| Road Traffic Accident |
Other Serious |
|
|
Female |
|
8/15/2012 |
Pharmacist |
United States |
|
| Leg Amputation |
Disability |
1/1/2010 |
68 |
Female |
|
8/15/2012 |
Consumer |
United States |
|
| Lung Neoplasm Malignant |
Other Serious |
|
|
Female |
|
8/16/2012 |
Consumer |
United States |
|
| Cataract |
Other Serious |
1/1/2010 |
45 |
Male |
|
8/16/2012 |
Consumer |
United States |
|
| Restlessness |
Hospitalization |
6/26/2011 |
36 |
Male |
|
8/16/2012 |
Other Health Professional |
Japan |
|
| Cardiac Operation |
Hospitalization |
1/1/2012 |
79 |
Male |
|
8/17/2012 |
Consumer |
United States |
|
| Hospitalisation |
Hospitalization |
|
|
Female |
|
8/17/2012 |
Consumer |
United States |
|
| Therapeutic Response Unexpected |
Other Serious |
10/1/2011 |
56 |
Female |
|
8/20/2012 |
Consumer |
Canada |
|
| Hospitalisation |
Hospitalization |
1/1/2012 |
51 |
Female |
|
8/21/2012 |
Consumer |
United States |
|
| Femur Fracture |
Other Serious |
6/2010 |
73 |
Male |
150 lb |
11/23/2012 |
Consumer |
Br |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Loss Of Consciousness |
Hospitalization |
10/31/2011 |
56 |
Male |
185 lb |
12/28/2012 |
Physician |
Fr |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hip Fracture |
Other Serious |
7/6/2011 |
79 |
Male |
183 lb |
10/11/2012 |
Pharmacist |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Toe Amputation |
Disability |
2010 |
68 |
Female |
174 lb |
10/18/2012 |
Consumer |
Us |
|
| Hospitalisation |
Hospitalization |
2012 |
51 |
Female |
|
9/24/2012 |
Consumer |
Us |
|
| Urinary Retention |
Disability |
1/2011 |
57 |
Female |
143 lb |
10/1/2012 |
Consumer |
Br |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Aortic Valve Replacement |
Other Serious |
2012 |
61 |
Male |
|
10/26/2012 |
Consumer |
Us |
|
| Dizziness |
Hospitalization |
2012 |
76 |
Female |
|
8/29/2012 |
Consumer |
Us |
|
| Viith Nerve Paralysis |
Other Serious |
2008 |
53 |
Female |
|
8/29/2012 |
Consumer |
Us |
|
| Transient Ischaemic Attack |
Other Serious |
2010 |
|
Female |
|
8/31/2012 |
Consumer |
Us |
|
| Glaucoma |
Other Serious |
4/2012 |
74 |
Male |
|
9/4/2012 |
Consumer |
Br |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Visual Acuity Reduced |
Other Serious |
5/2012 |
67 |
Female |
208 lb |
10/11/2012 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Diabetic Eye Disease |
Hospitalization |
6/15/2012 |
81 |
Female |
|
8/30/2012 |
Consumer |
Us |
|
| Bladder Cancer |
Other Serious |
2009 |
81 |
Male |
|
9/6/2012 |
Consumer |
Us |
|
| Vertigo |
Hospitalization |
7/2012 |
76 |
Female |
258 lb |
9/19/2012 |
Consumer |
Us |
|
| Renal Disorder |
Hospitalization |
|
|
Female |
|
9/6/2012 |
Consumer |
Us |
|
| Death |
Death |
|
|
|
|
9/6/2012 |
Other Health Professional |
Us |
|
| Visual Impairment |
Other Serious |
|
79 |
Female |
|
9/7/2012 |
Consumer |
Us |
|
| Death |
Death |
|
|
Female |
|
9/7/2012 |
Consumer |
Us |
|
| Breast Cancer |
Hospitalization |
2/2011 |
68 |
Female |
214 lb |
11/9/2012 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cerebrovascular Accident |
Hospitalization |
5/2012 |
85 |
Male |
|
9/10/2012 |
Consumer |
Us |
|
| Renal Failure |
Other Serious |
|
|
Female |
|
9/10/2012 |
Consumer |
Us |
|
| Parkinson's Disease |
Other Serious |
|
76 |
Female |
178 lb |
10/23/2012 |
Consumer |
Us |
|
| Myocardial Infarction |
Hospitalization |
2012 |
85 |
Male |
|
9/14/2012 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Diabetes Mellitus Inadequate Control |
Other Serious |
|
|
Male |
|
9/14/2012 |
Consumer |
Ie |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Rotator Cuff Syndrome |
Other Serious |
3/29/2012 |
56 |
Male |
|
9/17/2012 |
Consumer |
Us |
|
| Death |
Death |
|
|
Male |
|
9/18/2012 |
Consumer |
Us |
|
| Hip Fracture |
Hospitalization |
|
|
Female |
|
9/18/2012 |
Consumer |
Us |
|
| Eye Haemorrhage |
Other Serious |
7/2012 |
68 |
Female |
|
9/20/2012 |
Consumer |
Us |
|
| Leg Amputation |
Hospitalization |
8/29/2012 |
75 |
Male |
|
10/4/2012 |
Consumer |
Za |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Eye Haemorrhage |
Other Serious |
2012 |
48 |
Female |
|
9/21/2012 |
Consumer |
Us |
|
| Vomiting |
Other Serious |
2012 |
12 |
Female |
|
10/24/2012 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Neoplasm Malignant |
Other Serious |
2007 |
60 |
Female |
236 lb |
9/24/2012 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Hospitalisation |
Hospitalization |
2012 |
88 |
Female |
|
9/24/2012 |
Pharmacist |
Us |
|
| Stent Placement |
Hospitalization |
12/25/2011 |
59 |
Male |
132 lb |
10/4/2012 |
Consumer |
Us |
|
| Localised Infection |
Other Serious |
9/2012 |
|
Male |
|
9/24/2012 |
Consumer |
Us |
|
| Pneumonia |
Other Serious |
2012 |
72 |
Female |
|
9/25/2012 |
Consumer |
Us |
|
| Lower Limb Fracture |
Other Serious |
8/2012 |
63 |
Female |
170 lb |
11/2/2012 |
Consumer |
Us |
|
| Myocardial Infarction |
Hospitalization |
2012 |
82 |
Male |
216 lb |
10/15/2012 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Lung Infection |
Hospitalization |
7/25/2012 |
47 |
Male |
|
10/4/2012 |
Consumer |
Za |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Neoplasm |
Other Serious |
9/18/2012 |
|
|
|
9/28/2012 |
Consumer |
Cn |
|
| Pulmonary Embolism |
Hospitalization |
1/2012 |
61 |
Female |
157 lb |
11/9/2012 |
Consumer |
Br |
|
| Skin Graft |
Hospitalization |
9/11/2012 |
52 |
Male |
|
10/1/2012 |
Consumer |
Za |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Abdominal Distension |
Disability |
5/30/2012 |
76 |
Female |
|
10/1/2012 |
Pharmacist |
Ca |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Transplant |
Other Serious |
9/2009 |
|
Female |
|
10/4/2012 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Syncope |
Other Serious |
9/2012 |
73 |
Male |
|
10/3/2012 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Medication Error |
Hospitalization |
2012 |
47 |
Female |
|
10/12/2012 |
Consumer |
Us |
|
| Shoulder Operation |
Hospitalization |
8/16/2012 |
66 |
Female |
|
10/3/2012 |
Consumer |
Za |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Atrial Fibrillation |
Hospitalization |
9/2012 |
74 |
Female |
|
10/4/2012 |
Consumer |
Us |
|
| Tuberculosis |
Hospitalization |
9/19/2012 |
53 |
Male |
|
10/4/2012 |
Consumer |
Za |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Metastases To Liver |
Other Serious |
2/2012 |
|
Female |
|
10/4/2012 |
Consumer |
Us |
|
| Rotator Cuff Repair |
Other Serious |
9/2012 |
75 |
Female |
190 lb |
10/19/2012 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cerebrovascular Accident |
Hospitalization |
12/29/2011 |
74 |
Male |
|
10/8/2012 |
Consumer |
Us |
|
| Hospitalisation |
Hospitalization |
|
|
Female |
|
10/8/2012 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Periorbital Haematoma |
Other Serious |
2012 |
88 |
Female |
|
10/8/2012 |
Consumer |
Us |
|
| Visual Impairment |
Other Serious |
2011 |
|
Female |
|
10/8/2012 |
Consumer |
Us |
|
| Pyelonephritis |
Hospitalization |
2012 |
65 |
Male |
|
10/5/2012 |
Consumer |
Us |
|
| Visual Impairment |
Other Serious |
2011 |
|
Female |
|
10/8/2012 |
Consumer |
Us |
|
| Trigger Finger |
Other Serious |
|
|
Female |
|
10/8/2012 |
Consumer |
Us |
|
| Death |
Death |
7/7/2012 |
60 |
Female |
|
10/8/2012 |
Consumer |
Us |
|
| Wrist Fracture |
Other Serious |
11/2011 |
|
Female |
|
10/10/2012 |
Consumer |
Us |
|
| Thrombosis |
Hospitalization |
9/2012 |
69 |
Female |
215 lb |
11/30/2012 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Muscle Spasms |
Other Serious |
9/2012 |
60 |
Female |
|
10/10/2012 |
Consumer |
Us |
|
| Hospitalisation |
Hospitalization |
2012 |
94 |
Female |
|
10/15/2012 |
Consumer |
Us |
|
| Syncope |
Other Serious |
10/2/2012 |
|
Female |
|
10/15/2012 |
Consumer |
Us |
|
| Vena Cava Filter Insertion |
Hospitalization |
8/2011 |
75 |
Female |
|
10/15/2012 |
Consumer |
Us |
|
| Sinusitis |
Hospitalization |
2012 |
9 |
Male |
|
10/22/2012 |
Consumer |
Us |
|
| Headache |
Other Serious |
|
|
Female |
|
10/15/2012 |
Consumer |
Us |
|
| Foot Fracture |
Other Serious |
|
70 |
Female |
|
10/16/2012 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Urinary Tract Infection |
Hospitalization |
2012 |
72 |
Male |
|
10/17/2012 |
Consumer |
Us |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|