Fresh Frozen Plasma combined with Protamine Sulfate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Thrombotic Stroke Disability 4/28/2005 45 Male 2/21/2006 Physician France
Primary
Concomitant
Delayed Recovery From Anaesthesia Hospitalization 4/8/2005 77 Female 3/10/2006 Physician Japan
Primary
Secondary
Concomitant
Therapeutic Response Decreased Other Serious 5/5/2004 66 Male 225 lb 4/6/2006 Physician United States
Primary
Concomitant
Death Death 5/1/2004 78 Male 161 lb 4/6/2006 Physician United States
Primary
Concomitant
Death Death 3/18/2004 77 Male 207 lb 4/12/2006 Physician United States
Primary
Concomitant
Death Death 4/24/2004 61 Male 181 lb 4/12/2006 Physician United States
Primary
Concomitant
Sinusitis Hospitalization 56 Female 216 lb 4/13/2006 Other Health Professional Australia
Primary
Concomitant
Subclavian Vein Thrombosis Other Serious 8/22/2005 67 Female 159 lb 8/21/2006 Australia
Primary
Concomitant
Renal Failure Acute Other Serious 57 Male 8/21/2006 Australia
Primary
Concomitant
Arterial Thrombosis Other Serious 9/29/2005 64 Male 148 lb 11/13/2006 Physician Australia
Primary
Concomitant
Intracardiac Thrombus Death 75 1/24/2007 Other Health Professional Germany
Primary
Concomitant
Renal Vein Thrombosis Other Serious 1 Male 18 lb 3/16/2007 Physician Australia
Primary
Concomitant
Wound Infection Bacterial Other Serious 26 Female 7/12/2007 Other Health Professional Australia
Primary
Secondary
Concomitant
Thrombosis Disability 17 Female 154 lb 9/7/2007 Physician Canada
Primary
Concomitant
Stent Occlusion Other Serious 4/1/2007 65 Male 157 lb 8/6/2007 Physician United States
Primary
Concomitant
Ventricular Failure Other Serious 78 Female 9/20/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Other Serious 9/6/2007 33 Male 154 lb 6/24/2008 Physician Australia
Primary
Concomitant
Right Ventricular Failure Life Threatening 79 Female 7/23/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Hospitalization 9/1/2007 33 Male 8/22/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Hospitalization 9/1/2007 33 Male 8/28/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Peripheral Ischaemia Hospitalization 6 Male 57 lb 6/10/2009 Physician Australia
Primary
Concomitant
Multi-organ Failure Hospitalization 6/1/2008 61 Male 196 lb 6/11/2009 Physician Australia
Primary
Concomitant
Wound Infection Bacterial Other Serious 26 Female 11/12/2009 United Kingdom
Primary
Secondary
Concomitant
Wound Infection Bacterial Other Serious 26 Female 11/12/2009 United Kingdom
Primary
Secondary
Concomitant
Cardiogenic Shock Death 9/8/2006 60 Female 277 lb 3/8/2011 Lawyer United States
Primary
Concomitant
Fear Other Serious 9/8/2006 60 Female 277 lb 3/8/2011 Other Health Professional United States
Primary
Concomitant
Fear Other Serious 12/5/2006 74 Female 225 lb 3/14/2011 Other Health Professional United States
Primary
Concomitant
Pain Death 9/1/2005 66 Female 175 lb 3/18/2011 Other Health Professional United States
Primary
Concomitant
Multi-organ Failure Death 12/17/2002 79 Female 244 lb 3/18/2011 Lawyer United States
Primary
Concomitant
Pain Death 9/1/2005 66 Female 175 lb 3/18/2011 Lawyer United States
Primary
Concomitant
Renal Failure Death Male 181 lb 3/21/2011 Other Health Professional United States
Primary
Concomitant
Renal Failure Death Male 181 lb 3/21/2011 Other Health Professional United States
Primary
Concomitant
Injury Death 1/1/2006 60 Male 181 lb 3/21/2011 Lawyer United States
Primary
Concomitant
Unevaluable Event Other Serious 3/11/2006 63 Female 160 lb 3/22/2011 Consumer United States
Primary
Concomitant
Pain Other Serious 3/11/2006 63 Female 160 lb 3/22/2011 Consumer United States
Primary
Concomitant
Pain Hospitalization 10/11/2006 40 Female 375 lb 3/22/2011 Consumer United States
Primary
Concomitant
Unevaluable Event Other Serious Male 175 lb 3/23/2011 Other Health Professional United States
Primary
Concomitant
Injury Hospitalization 9/2/2004 59 Female 229 lb 3/29/2011 Other Health Professional United States
Primary
Concomitant
Pain Hospitalization 9/2/2004 59 Female 229 lb 3/29/2011 Other Health Professional United States
Primary
Concomitant
Pain Hospitalization 9/30/2005 82 Female 120 lb 3/29/2011 Other Health Professional United States
Primary
Concomitant
Anxiety Hospitalization 9/30/2005 82 Female 120 lb 3/29/2011 Consumer United States
Primary
Concomitant
Disability Hospitalization Male 313 lb 3/29/2011 Consumer United States
Primary
Concomitant
Renal Failure Acute Other Serious 10/1/2001 58 Male 3/29/2011 Consumer United States
Primary
Concomitant
Anxiety Other Serious 8/7/2007 8 Male 35 lb 3/31/2011 Other Health Professional United States
Primary
Concomitant
Stress Other Serious Female 139 lb 3/31/2011 Lawyer United States
Primary
Concomitant
Anxiety Other Serious 1/1/2005 68 Female 162 lb 3/31/2011 Other Health Professional United States
Primary
Concomitant
Fear Death 1/1/2005 68 Female 162 lb 3/31/2011 Lawyer United States
Primary
Concomitant
Pain Death 8/3/2007 73 Female 130 lb 3/31/2011 Other Health Professional United States
Primary
Concomitant
Death Death 8/3/2007 73 Female 130 lb 3/31/2011 Consumer United States
Primary
Concomitant
Fear Other Serious 12/7/1999 61 Male 212 lb 4/4/2011 Consumer United States
Primary
Concomitant
Unevaluable Event Other Serious 3/12/2007 58 Male 198 lb 4/5/2011 Other Health Professional United States
Primary
Concomitant
Multi-organ Failure Other Serious 12/26/2000 59 Male 110 lb 4/5/2011 Consumer United States
Primary
Concomitant
Pain Death 9/7/1998 80 Male 174 lb 4/5/2011 Consumer United States
Primary
Concomitant
Stress Other Serious 9/7/1998 80 Male 174 lb 4/5/2011 Other Health Professional United States
Primary
Concomitant
Injury Hospitalization 12/11/2003 53 Male 158 lb 4/5/2011 Lawyer United States
Primary
Concomitant
Disability Other Serious 3/12/2007 58 Male 198 lb 4/5/2011 Lawyer United States
Primary
Concomitant
Pain Hospitalization 12/26/2000 59 Male 110 lb 4/5/2011 Other Health Professional United States
Primary
Concomitant
Fear Hospitalization 11/28/2004 55 Male 4/6/2011 Consumer United States
Primary
Concomitant
Multi-organ Failure Hospitalization 1/9/1998 66 Male 185 lb 4/6/2011 Lawyer United States
Primary
Concomitant
Pain Other Serious 1/28/2004 61 Female 126 lb 4/7/2011 Other Health Professional United States
Primary
Concomitant
Pain Other Serious 12/1/2006 56 Female 173 lb 4/7/2011 Other Health Professional United States
Primary
Concomitant
Unevaluable Event Other Serious 12/1/2006 56 Female 173 lb 4/7/2011 Other Health Professional United States
Primary
Concomitant
Unevaluable Event Other Serious Female 100 lb 4/8/2011 Lawyer United States
Primary
Concomitant
Pain Death 1/22/2005 61 Female 161 lb 4/7/2011 Lawyer United States
Primary
Concomitant
Renal Injury Other Serious 1/22/2005 61 Female 161 lb 4/7/2011 Lawyer United States
Primary
Concomitant
Pain Other Serious 6/26/2002 43 Male 139 lb 4/8/2011 Lawyer United States
Primary
Concomitant
Anxiety Other Serious 11/21/2003 71 Female 155 lb 4/14/2011 Lawyer United States
Primary
Secondary
Concomitant
Stress Death 1/1/2005 68 Female 162 lb 4/14/2011 Consumer United States
Primary
Concomitant
Renal Injury Other Serious 3/25/2004 83 Male 215 lb 4/14/2011 Physician United States
Primary
Concomitant
Unevaluable Event Other Serious 3/25/2004 83 Male 215 lb 4/14/2011 Physician United States
Primary
Concomitant
Injury Other Serious 6/8/2005 51 Male 140 lb 4/14/2011 Other Health Professional United States
Primary
Concomitant
Pain Other Serious 10/14/2005 54 Male 167 lb 4/15/2011 Other Health Professional United States
Primary
Concomitant
Mental Disorder Other Serious 3/9/2007 58 Male 198 lb 4/15/2011 Lawyer United States
Primary
Concomitant
Death Other Serious 8/15/2003 76 Female 140 lb 4/15/2011 Other Health Professional United States
Primary
Concomitant
Pain Other Serious Male 4/15/2011 Lawyer United States
Primary
Concomitant
Unevaluable Event Death 65 Male 160 lb 4/15/2011 Consumer United States
Primary
Concomitant
Emotional Distress Hospitalization 6/22/2005 56 Male 251 lb 4/15/2011 Lawyer United States
Primary
Concomitant
Anhedonia Hospitalization 3/1/2003 66 Male 154 lb 4/18/2011 Consumer United States
Primary
Concomitant
Renal Impairment Death 5/21/2004 76 Male 170 lb 4/19/2011 Other Health Professional United States
Primary
Concomitant
Depression Other Serious 6/22/2005 56 Male 200 lb 4/19/2011 Consumer United States
Primary
Concomitant
Adverse Event Death 3/19/2005 53 Male 205 lb 4/19/2011 Lawyer United States
Primary
Concomitant
Injury Other Serious 5/21/2004 76 Male 170 lb 4/19/2011 Other Health Professional United States
Primary
Concomitant
Stress Other Serious 52 Male 275 lb 4/20/2011 Other Health Professional United States
Primary
Concomitant
Injury Hospitalization 4/19/2004 62 Female 200 lb 4/20/2011 Other Health Professional United States
Primary
Concomitant
Pain Hospitalization 8/25/2004 61 Male 233 lb 4/21/2011 Lawyer United States
Primary
Concomitant
Pain Hospitalization 61 Female 204 lb 4/21/2011 Lawyer United States
Primary
Concomitant
Multi-organ Failure Other Serious 2/2/2007 57 Male 274 lb 4/21/2011 Physician United States
Primary
Concomitant
Unevaluable Event Other Serious 11/4/2004 60 Female 140 lb 4/21/2011 Lawyer United States
Primary
Concomitant
Unevaluable Event Other Serious 10/29/2007 68 Male 164 lb 4/22/2011 Other Health Professional United States
Primary
Concomitant
Emotional Distress Other Serious 10/1/2001 58 Male 4/22/2011 Other Health Professional United States
Primary
Concomitant
Emotional Distress Other Serious 8/25/2004 61 Male 233 lb 4/25/2011 Consumer United States
Primary
Concomitant
Pain Death 4/4/2000 49 Male 337 lb 4/26/2011 Consumer United States
Primary
Concomitant
Pain Other Serious 3/8/2003 61 Male 185 lb 4/26/2011 Lawyer United States
Primary
Concomitant
Renal Injury Other Serious 10/28/2005 76 Female 49 lb 4/27/2011 Other Health Professional United States
Primary
Concomitant
Unevaluable Event Death 11/2/2007 77 Male 175 lb 4/27/2011 Consumer United States
Primary
Concomitant
Anhedonia Other Serious 6/7/2003 56 Male 170 lb 4/27/2011 Lawyer United States
Primary
Concomitant
Unevaluable Event Other Serious 1/1/2002 53 Female 280 lb 4/28/2011 Lawyer United States
Primary
Concomitant
Injury Other Serious 3/18/2002 1 Male 11 lb 4/29/2011 Consumer United States
Primary
Concomitant
Fear Other Serious 1/27/2003 64 Male 310 lb 4/29/2011 Other Health Professional United States
Primary
Concomitant
Injury Other Serious 12/31/2004 57 Male 251 lb 5/2/2011 Consumer United States
Primary
Concomitant
Unevaluable Event Other Serious 11/14/2000 41 Female 249 lb 5/2/2011 Consumer United States
Primary
Concomitant
Renal Impairment Hospitalization 10/26/2006 80 Female 180 lb 5/2/2011 Lawyer United States
Primary
Concomitant
Emotional Distress Other Serious 9/29/2004 79 Male 170 lb 5/2/2011 Other Health Professional United States
Primary
Concomitant
Injury Other Serious 11/28/2004 58 Male 189 lb 5/2/2011 Consumer United States
Primary
Concomitant
Mental Disorder Other Serious 5/25/2006 68 Male 210 lb 5/3/2011 Other Health Professional United States
Primary
Concomitant
Unevaluable Event Other Serious 3/11/2006 63 Female 160 lb 5/2/2011 Consumer United States
Primary
Concomitant
Anhedonia Other Serious 8/5/2004 51 Male 173 lb 5/4/2011 Other Health Professional United States
Primary
Concomitant
Emotional Distress Other Serious 52 Male 275 lb 5/4/2011 Consumer United States
Primary
Concomitant
Fear Of Death Other Serious 6/26/2002 43 Male 139 lb 5/6/2011 Consumer United States
Primary
Concomitant
Depression Other Serious 49 Male 194 lb 5/7/2011 Consumer United States
Primary
Concomitant
Renal Failure Death 9/26/2004 68 Male 240 lb 5/7/2011 Consumer United States
Primary
Concomitant
Anhedonia Death 9/28/2007 44 Male 178 lb 5/7/2011 Lawyer United States
Primary
Concomitant
Injury Other Serious 2/15/1999 36 Male 178 lb 5/7/2011 Lawyer United States
Primary
Concomitant
Pain Death 9/3/2003 80 Male 175 lb 5/7/2011 Lawyer United States
Primary
Concomitant
Renal Failure Other Serious 10/8/2005 68 Female 148 lb 5/9/2011 Physician United States
Primary
Concomitant
Renal Injury Hospitalization 1/1/2006 61 Female 136 lb 5/10/2011 Other Health Professional United States
Primary
Concomitant
Renal Impairment Other Serious 72 Male 212 lb 5/11/2011 Lawyer United States
Primary
Concomitant
Unevaluable Event Other Serious 12/2/2006 55 Female 289 lb 5/11/2011 Lawyer United States
Primary
Concomitant
Anxiety Other Serious 11/4/2004 67 Male 234 lb 5/12/2011 Other Health Professional United States
Primary
Concomitant
Anxiety Other Serious 5/21/2004 76 Male 170 lb 5/12/2011 Other Health Professional United States
Primary
Concomitant
Renal Impairment Hospitalization 12/7/1999 61 Male 212 lb 5/12/2011 Consumer United States
Primary
Concomitant
Anhedonia Other Serious 6/17/2003 79 Female 198 lb 5/12/2011 Consumer United States
Primary
Concomitant
Injury Death 3/31/2005 58 Male 5/13/2011 Other Health Professional United States
Primary
Concomitant
Renal Failure Hospitalization 1/11/2006 65 Male 183 lb 5/13/2011 Other Health Professional United States
Primary
Concomitant
Injury Other Serious 2/17/2002 53 Female 164 lb 5/13/2011 Lawyer United States
Primary
Concomitant
Anxiety Other Serious 1/1/2006 77 Male 141 lb 5/14/2011 Lawyer United States
Primary
Concomitant
Depression Other Serious 6/5/2007 54 Female 138 lb 5/16/2011 Other Health Professional United States
Primary
Concomitant
Anxiety Death 71 Female 145 lb 5/14/2011 Other Health Professional United States
Primary
Concomitant
Renal Impairment Other Serious 3/17/2005 65 Female 157 lb 5/17/2011 Consumer United States
Primary
Concomitant
Unevaluable Event Other Serious 4/24/2004 82 Male 183 lb 5/17/2011 Other Health Professional United States
Primary
Concomitant
Emotional Distress Hospitalization 4/19/2004 62 Female 200 lb 5/17/2011 Lawyer United States
Primary
Concomitant
Renal Impairment Other Serious 62 Female 210 lb 5/17/2011 Other Health Professional United States
Primary
Concomitant
Renal Failure Other Serious 3/1/2003 66 Male 154 lb 5/18/2011 Consumer United States
Primary
Concomitant
Injury Death 1/7/2002 79 Female 132 lb 5/19/2011 Other Health Professional United States
Primary
Concomitant
Anxiety Death Male 192 lb 5/20/2011 Other Health Professional United States
Primary
Concomitant
Pain Death 6/17/2003 79 Female 198 lb 5/21/2011 Lawyer United States
Primary
Concomitant
Renal Tubular Necrosis Hospitalization 6/22/2005 56 Male 200 lb 5/21/2011 Lawyer United States
Primary
Concomitant
Injury Other Serious 4/7/1997 51 Male 158 lb 5/23/2011 Lawyer United States
Primary
Concomitant
Anxiety Other Serious 7/1/2004 54 Male 227 lb 5/24/2011 Consumer United States
Primary
Concomitant
Unevaluable Event Other Serious 2/6/2003 77 Male 126 lb 5/25/2011 Lawyer United States
Primary
Concomitant
Unevaluable Event Other Serious 4/1/2005 78 Female 150 lb 5/26/2011 Lawyer United States
Primary
Concomitant
Death Death 1/12/2001 16 Male 115 lb 5/26/2011 Lawyer United States
Primary
Concomitant
Renal Failure Other Serious 7/24/1994 53 Female 155 lb 5/28/2011 Other Health Professional United States
Primary
Concomitant
Renal Injury Hospitalization 11/27/2004 55 Male 189 lb 6/1/2011 Consumer United States
Primary
Concomitant
Fear Other Serious 3/25/2006 64 Female 220 lb 6/2/2011 Other Health Professional United States
Primary
Concomitant
Injury Other Serious 10/12/2003 79 Female 117 lb 6/3/2011 Physician United States
Primary
Concomitant
Injury Other Serious 8/26/2004 80 Male 227 lb 6/3/2011 Consumer United States
Primary
Concomitant
Multi-organ Failure Other Serious 7/28/2007 63 Male 218 lb 6/3/2011 Lawyer United States
Primary
Concomitant
Mental Status Changes Other Serious 3/1/2007 77 Male 181 lb 6/6/2011 Consumer United States
Primary
Concomitant
Pain Other Serious 11/20/2004 23 Female 135 lb 6/4/2011 Other Health Professional United States
Primary
Concomitant

Drug Data