Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-4092

2. Registrant Information.

Registrant Reference Number: 2022-US-001929

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

Address: 150 Research Lane, Suite 225

City: Guelph

Prov / State: ON

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.

04-APR-22

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

24-MAR-22

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.       PMRA Submission No.       EPA Registration No. 83399-6

Product Name: VECTRA 3D FOR DOGS 56-95 LBS

• 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.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

4.7

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?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

English Bull Dog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

24.948

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• Respiratory System
  • Symptom - Dyspnea
  • Symptom - Tachypnea

• General
  • Symptom - Hyperactivity
  • Symptom - Insomnia
  • Specify - Sleep disturbance

• Skin
  • Symptom - Other
  • Specify - Application site skin change

• Respiratory System
  • Symptom - Other
  • Specify - Hypoplastic trachea
  • Symptom - Other
  • Specify - Bronchopulmonary inflammation

12. How long did the symptoms last?

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

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?

7

Day(s) / Jour(s)

15. Outcome of the incident

Euthanised / Euthanasie

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

Attending veterinarian concluded that the dogs decline was not related to the product but rather related to chronic pneumonia and poor genetics (medical record details several treatments for pneumonia and genetic disease).

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To be determined by Registrant

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

Major

19. Provide supplemental information here