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`http:/lwww.fda.govlSafetylMedWatch/HowToReport/ucm053087.htm
`175 captures
`11 Jun 09 - 11 Aug 14
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`2003 11 ’
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`201
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`Safety
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`What is a Serious Adverse Event?
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`An adverse event is any undesirable experience associated with the use of a medical product in a
`patient. The event is serious and should be reported when the patient outcome is:
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`Death
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`Report if the patient's death is suspected as being a direct outcome of the adverse
`event.
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`Life-Threatening
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`Report if the patient was at substantial risk of dying at the time of the adverse event or
`it is suspected that the use or continued use of the product would result in the patient's
`death.
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`Examples: Pacemaker failure; gastrointestinal hemorrhage; bone marrow suppression;
`infusion pump failure which permits uncontrolled free flow resulting in excessive drug
`dosing.
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`Hospitalization (initial or prolonged)
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`Report if admission to the hospital or prolongation of a hospital stay results because of
`the adverse event.
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`Examples: Anaphylaxis; pseudomembranous colitis; or bleeding causing or prolonging
`hospitalization.
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`Disability
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`Report if the adverse event resulted in a significant, persistent, or permanent change,
`impairment, damage or disruption in the patient's body function/structure, physical
`activities or quality of life.
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`Examples: Cerebrovascular accident due to drug—induced hypercoagulability; toxicity;
`peripheral neuropathy.
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`Congenital Anomaly
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`Report if there are suspicions that exposure to a medical product prior to conception or
`during pregnancy resulted in an adverse outcome in the child.
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`Examples: Vaginal cancer in female offspring from diethylstilbestrol during pregnancy;
`malformation in the offspring caused by thalidomide.
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`Requires Intervention to Prevent Permanent Impairment or Damage
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`PRAXAIR 1013
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`001
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`002
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`002