Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2012-2100
2. Registrant Information.
Registrant Reference Number: 2012CA00456
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.
14-MAY-12
5. Location of incident.
Country: CANADA
Prov / State: SASKATCHEWAN
6. Date incident was first observed.
13-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: 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 Reaction: On 13 May 2012 an owner treated her dog with Defend. Shortly after, the dog began vocalizing, panting was restless and sleepless all night and the owner noted that the dog was possibly drinking more. The next morning the owner gave the dog a bath and noticed that the dog seemed more comfortable after the bath. The clinic will call the owner for a follow-up, details were requested, ongoing. Update 15 May 2012, the clinic reported that the pet owner gave the dog an additional bath as the dog was still restless, owner's words "twitchy". The dog improved after the second bath. The dog has not been examined by the veterinarian. The case is ongoing. Update 06 June 2012, a follow-up was requested to the clinic. The vet technician had tried several times to contact the pet owner for a follow-up on the pet. The phone calls were never returned. The case is lost to follow-up, 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
Bichon Fris cross with a Shih Tzu
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
11.8
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
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Nervous and Muscular Systems
- Symptom - Muscle twitching
- Specify - 'twitchy'
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
Unknown/Inconnu
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 dog was bathed twice by the pet owner.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here