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Report an Adverse Drug Reaction
To report an adverse drug reaction please fill out the form below, scroll to the bottom of the page and click "Submit"
A. Patient Information
1. Patient identifier
2. Age at time of reaction
3. Sex
4. Height
5. Weight
male
feet
lbs
Chart Number
Date of birth
or
or
female
cm
kgs
B. Adverse Reaction
1. Outcome attributed to adverse reaction(check all that apply)
Death
Disability
Life Threatening
Congenital Malformation
Hospitalization
Required intervention to prevent
damage / permanent impairment
Hospitalization-Prolonged
Other:
2. Date and time of reaction
(dd/mm/yyyy)
3. Date of this report
(dd/mm/yyyy)
4. Describe reaction or problem
5. Revelant tests / laboratory data (including dates (dd/mm/yyyy))
Submission of a report does not constitute an admission that medical personel or the product caused or contributed to the adverse reaction.
C. Suspected drug products(s)
1. Name (give labelled strength & manufacturer, if known).
#1
#2
2. Dose, frequency, & route used
3. Therapy dates(if known, give duration).
From (dd/mm/yyyy) to (dd/mm/yyyy)
#1
#1
#2
#2
4. Indication for use of suspected drug
product
5. Reaction abated after use stopped or
dose reduced.
#1
#1
Yes
No
Doesn't apply
#2
#2
Yes
No
Doesn't apply
6. Lot # (if known)
7. Exp. Date (if known)
(dd/mm/yyyy)
8. Reaction reappeared after
reintroduction
#1
#1
#1
Yes
No
Doesn't apply
#2
#2
#2
Yes
No
Doesn't apply
9. Concomittant drugs(name, dose, frequency and route used) and therapy dates
(dd/mm/yyyy)(exclude treatment of reaction)
10. Treatment of adverse reaction
(drugs and/or therapy), including dates(dd/mm/yyy)
D. Reporter
1. Name, address, email, & phone number.
2. Health
professional?
3. Occupation
4. Also reported to
manufacturer?
Yes
No
Yes
No
E. Suspect Medical Device
1. Brand name
2. Type of device
3. Manufacturer name & address
4. Operator of device
Health professional
Lay user/patient
Other
5. Expiration date
(dd/mm/yyyy)
7. If implanted, give date
(dd/mm/yyyy)
8. If explanted, give date
(dd/mm/yyyy)
6.
Model #
Serial #
Catalog #
Lot #
Other
9. Device available for evaluation? (Do not send) (dd/mm/yyy)
Yes
No
returned to manufacturer on
10. Concomitant medical products and therapy dates (exclude treatment of event)
(dd/mm/yyy)
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