Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-1710

2. Registrant Information.

Registrant Reference Number: 2022-CA-000030

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

Address: 150 Research Lane, Suite 225

City: Ontario

Prov / State: Guelph

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.

28-JUL-22

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

21-JUL-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. 33420      PMRA Submission No.       EPA Registration No.

Product Name: Vectra 3D for Dogs and Puppies Over 7 weeks of age 9.1 to 25 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.

3.6

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?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Pug

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

8.98

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Skin
  • Symptom - Itchy skin
  • Symptom - Hair loss
  • Symptom - Lesion

• Gastrointestinal System
  • Symptom - Weight loss

• General
  • Symptom - Lethargy

• Skin
  • Symptom - Other
  • Specify - Puss
  • Symptom - Red skin

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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 entire pipette was applied in a circle between the two shoulder blades. Symptoms appeared on July 24, 2022 - 48- 72 hours after application. Cutaneous reaction between the shoulder blades. Hair loss and intense itching. Redness and presence of purulent wound. Clinical signs lasted until veterinary examination and prescription of medication (cephalex antibiotic 250 mg) on July 26, 2022. Patient still on treatment and not fully recovered at the time of the report on July 28, 2022.

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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

Owner followed up 10-Aug-22 to report dog lost weight (no actual number provided) but that it was eating normally again. Cutaneous lesion persist and are still being cleaned and disinfected (hair has not grown back). Owner reports dog seems lethargic and it not its usual self. The 'skin symptoms' were reported by veterinary clinic by the GI and General symptoms above were only reported by owner and not the vet. No further follow up was available.