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Consumer Product Safety

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

  • Active Ingredient(s)
    • PERMETHRIN

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

  • General
    • Symptom - Vocalizing
  • Respiratory System
    • Symptom - Panting
  • General
    • Symptom - Discomfort
  • Nervous and Muscular Systems
    • Symptom - Restlessness
  • General
    • Symptom - Polydipsia
  • 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