Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-3640
2. Registrant Information.
Registrant Reference Number: 2011-CA-00868
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.
28-JUL-11
5. Location of incident.
Country: CANADA
Prov / State: NOVA SCOTIA
6. Date incident was first observed.
21-JUL-11
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.
PMRA Submission No.
EPA Registration No. 773-73
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).
Suspect lack of efficacy was reported by the pet owner. The owner applied 1 ml of the Defend to her dog's back on 21 July 2011 and still see many fleas on it's body. The pet was scratching prior to treatment and continues to scratch. The dog has not been washed or in the rain since application. The owner has used this product on other pets in the past successfully. The case is closed.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Boxer mix
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
1.0
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
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
12. How long did the symptoms last?
>1 wk <=1 mo / > 1 sem < = 1 mois
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
Suspect lack of efficacy was reported by the pet owner. The owner applied 1 ml of the Defend to her dog's back on 21 July 2011 and still see many fleas on it's body. The pet was scratching prior to treatment and continues to scratch. The dog has not been washed or in the rain since application. The owner has used this product on other pets in the past successfully. The case is closed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here