Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-1839

2. Registrant Information.

Registrant Reference Number: 2020-CA-000024

Registrant Name (Full Legal Name no abbreviations): Ceva Animal Health Inc.

Address: 6-1040 Fountain St. N.

City: Cambridge

Prov / State: Ontario

Country: Canada

Postal Code: N2E 1A3

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

Domestic Animal

4. Date registrant was first informed of the incident.

23-JUL-20

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

22-MAY-20

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. 33421      PMRA Submission No.       EPA Registration No.

Product Name: Vectra 3D for Dogs and Puppies Over 7 Weeks Weighing 4.6 to 9.0 kg

• Active Ingredient(s)
  • DINOTEFURAN
    • Guarantee/concentration 4.95 %
  • PERMETHRIN
    • Guarantee/concentration 36.08 %
  • PYRIPROXYFEN
    • Guarantee/concentration .44 %

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.6

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).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

Griffon

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0

Unknown

7. Weight (provide a range if necessary )

8

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

• General
  • Symptom - Parasitism
  • Specify - Lack of efficacy, found bloated tick on puppy 3 weeks after treatment

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

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

The owner found a bloated tick on the puppy 3 weeks after treatment with Vectra 3D.

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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