Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2012-2092
2. Registrant Information.
Registrant Reference Number: 2012CA00452
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.
10-MAY-12
5. Location of incident.
Country: CANADA
Prov / State: SASKATCHEWAN
6. Date incident was first observed.
07-MAY-12
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: mg/L
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).
Adverse event reaction reported by the clinic. A dog was treated with the first dose of Defend on 01 April and no reaction occurred. A second dose of Defend on 07 May 2012 was applied in between the shoulder blades and developed a localized reaction within 30 minutes of application. The area became red and inflamed and the dog was scratching at the site. The pet owners bathed the dog immediately and applied Polysporin to the site. The dog has recovered, 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
Shih Tzu cross with Maltese
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
1
7. Weight (provide a range if necessary )
Unknown
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
>30 min <=2 hrs / >30 min <=2 h
11. List all symptoms
System
- Skin
- Symptom - Pruritus
- Symptom - Inflammation of the skin
- Symptom - Red skin
12. How long did the symptoms last?
Unknown / Inconnu
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 owners bathed the dog immediately and applied Polysporin to the site.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here