Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-2324

2. Registrant Information.

Registrant Reference Number: 2013-CA-00198

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.

12-MAR-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

12-MAR-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)

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PMRA Registration No. 27829      PMRA Submission No.       EPA Registration No.

Product Name: SABER POUR ON

• Active Ingredient(s)
  • LAMBDA-CYHALOTHRIN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 reported by the clinic to the poison control center on 12 Mar 2013. Accidental exposure involved ingesting possibly 100.0 ml orally of Saber Pour On. Poison control originally reported it as Ultra Saber Pour On and corrected the product name upon follow-up on same day. Approximately 5 hours post exposure the dog began to vomit. It is unknown if the dog was treated, however was advised to treat with anti emetic, Methocarbamol and IV fluids. The outcome is unknown, 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

Australian Shepherd

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

52.0

lbs

8. Route(s) of exposure

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Accidental ingestion/Ingestion accident.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

It was advised to treat with an anti emetic, Methocarbamol and IV fluids, however not known if treatment was given.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Minor

19. Provide supplemental information here