Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-1593

2. Registrant Information.

Registrant Reference Number: 2023-CA-000044

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.

24-MAY-23

5. Location of incident.

Country: CANADA

Prov / State: SASKATCHEWAN

6. Date incident was first observed.

01-MAY-23

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. 34604      PMRA Submission No.       EPA Registration No.

Product Name: VECTRA 3D DOGS & PUPPIES OVER 7 WEEKS WEIGHING 2.0 KG TO 4.5 KG

• Active Ingredient(s)
  • DINOTEFURAN
  • PERMETHRIN
  • PYRIPROXYFEN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

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).

On April 30th at 7pm, the dog (a Pomeranian X ) was given one tube of Vectra 3D, between his shoulder blades applied directly to the skin, and it was noted, that he kept trying to rub it off.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Pomeranian mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

Unknown

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

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

11. List all symptoms

System

• Skin
  • Symptom - Pruritus

• General
  • Symptom - Hyperactivity

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Lethargy
  • Symptom - Adipsia
  • Symptom - Abnormal behaviour
  • Symptom - Hesitancy to move

12. How long did the symptoms last?

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

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

On May 1, the dog owner opened the crate, the dog exited and spun in a circle, sat down, and scratched himself, when he normally runs out to immediately urinate. The dog owner had to take the dog out to urinated, but the dog spun in a circle and sat still, and he kept scratching at irregular intervals. After 5 minutes, the owner had to pick him up and bring him inside, as he would not move on his own. He refused to eat or drink anything over the course of the day, exhibiting much of the same spinning, sitting, scratching behaviour. On May 2 he was still doing the same, so the owner had to use a syringe to give him water into his mouth, and he unwillingly ate a hard-boiled egg and wet food. On May 3rd & 4th, he was still the same. On May 5th we given Benadryl, and he stopped scratching and acted more normal. The next morning, he was acting weird again, so more Benadryl was given. He didn't start acting normal on his own again until May 7th , he was still scratching more than normal but ate and drank of his own will. He is now acting normal and is doing fine.

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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