`
`”M
`
`JUN
`AU‘
`http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053087.htm
`11 ’
`ca tures
`Imam”
`[In
`Lp_
`2009
`201
`11 Jun09-11 Aug 14
`
`
`Go
`
`MAY
`
`luuhdhfi... 2003
`
`Safety
`
`What is a Serious Adverse Event?
`
`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:
`
`Death
`
`Report if the patient's death is suspected as being a direct outcome of the adverse
`event.
`
`Life-Threatening
`
`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.
`
`Examples: Pacemaker failure; gastrointestinal hemorrhage; bone marrow suppression;
`infusion pump failure which permits uncontrolled free flow resulting in excessive drug
`dosing.
`
`Hospitalization (initial or prolonged)
`
`Report if admission to the hospital or prolongation of a hospital stay results because of
`the adverse event.
`
`Examples: Anaphylaxis; pseudomembranous colitis; or bleeding causing or prolonging
`hospitalization.
`
`Disability
`
`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.
`
`Examples: Cerebrovascu/ar accident due to drug-induced hypercoagu/abi/ity; toxicity;
`peripheral neuropathy.
`
`Congenital Anomaly
`
`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.
`
`Examples: Vaginal cancer in female offspring from diethy/sti/bestrol during pregnancy;
`malformation in the offspring caused by thalidomide.
`
`Requires Intervention to Prevent Permanent Impairment or Damage
`
`001
`
`PRAXAIR 1013
`
`001
`
`
`
`Report if you suspect that the use of a medical product may result in a condition which
`required medical or surgical intervention to preclude permanent impairment or damage
`to a patient.
`Examples: Acetaminophen overdose-induced hepatotoxicity requiring treatment with
`acety/cysteine to prevent permanent damage; burns from radiation equipment requiring
`drug therapy; breakage of a screw requiring replacement of hardware to prevent
`malunion of a fractured long bone.
`
`002
`
`002
`
`
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