Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-1619

2. Registrant Information.

Registrant Reference Number: 2023-CA-000042

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.

11-MAY-23

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

09-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 May 9th, 2023 a the dog owner applied Vectra 3D on the spine up to the tail, separating the fur.

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

Chihauhua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Skin
  • Symptom - Pruritus

• General
  • Symptom - Abnormal behaviour
  • Specify - Apathy, not 'feeling itself'

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.

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 9th, 2023 a the dog owner applied Vectra 3D on the spine up to the tail, separating the fur. One hour later, the dog experienced intense pruritis, apathy (amorphe), and not feeling like herself, and the symptoms lasted about 30 hours. The dog owner gave the dog a bath to soothe her, and no further treatment was needed.

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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