Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-3449
2. Registrant Information.
Registrant Reference Number: 2013-CA-00554
Registrant Name (Full Legal Name no abbreviations): Merck Animal Health (Intervet Canada Corp)
Address: 16750 Transcanada Highway
City: Kirkland
Prov / State: Quebec
Country: Canada
Postal Code: H9H 4M7
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
19-JUN-13
5. Location of incident.
Country: CANADA
Prov / State: MANITOBA
6. Date incident was first observed.
18-JUN-13
Product Description
7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.
Active(s)
PMRA Registration No. 22968
PMRA Submission No.
EPA Registration No.
Product Name: Defend
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
Units: mL
10. Site pesticide was applied to (select all that apply).
Site: Animal / Usage sur un animal domestique
11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).
Suspected adverse event reaction reported by the clinic on 19 Jun 2013. A dog was treated with Defend on 17 Jun 2013. The following day, the pet owner reported that the dog was lethargic and inappetent. The pet owner decided to bath the dog on the 18 Jun 2013. The dog was examined on 19 Jun 2013, was found to be bright an alert, and exam findings were normal. The case is closed.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Maltese
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
3.0
7. Weight (provide a range if necessary )
3.93
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
<=15 min / <=15 min
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
12. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 h
13. Was medical treatment provided? Provide details in question 17.
No
14. a) Was the animal hospitalized?
No
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Fully Recovered / Complètement rétabli
16. How was the animal exposed?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
The pet owner decided to bath the dog on the 18 Jun 2013.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here