Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-3409

2. Registrant Information.

Registrant Reference Number: CA2017_000843

Registrant Name (Full Legal Name no abbreviations): Elanco Canada Ltd

Address: 150 Research Lane, Suite 120

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G 4T2

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

15-AUG-17

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

09-AUG-17

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. 28297      PMRA Submission No.       EPA Registration No.

Product Name: Agita 1GB Bait

• Active Ingredient(s)
  • (Z)-9-TRICOSENE
  • THIAMETHOXAM

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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: Other / Autre

Préciser le type: window frame of Horse barn

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

applied to a single site once a month

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Yorkshire terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

2.4

kg

8. Route(s) of exposure

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Lethargy

• Nervous and Muscular Systems
  • Symptom - Confusion

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Fully Recovered / Complètement rétabli

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

Suspected exposure, not confirmed. Surmised that a few granules may have fallen onto the floor from the location on the windowsill where it was placed. Neurological signs were described as "mentally absent". Treated symptomatically in hospital.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here