Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-1442

2. Registrant Information.

Registrant Reference Number: 2023-US-004409

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-JUL-23

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

12-JUN-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.       PMRA Submission No.       EPA Registration No. 83399-6-85581

Product Name: FIRST SHIELD TRIO FOR DOGS AND PUPPIES 11-20 LB

• 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.

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).

21Jun2023 A veterinarian reported an adverse reaction with Cytpoint in an adult canine in fair health and with no product reaction history. Concomitantly the dog received First Shield Trio since approximately 01Jan2023.On 10Jun2023 the dog was given a dose of Cytopoint, which she previously tolerated. The lot number was unavailable when requested. Date of last administration and frequency not available.

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

Havanese

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

20

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Blood
  • Symptom - Thrombocytopenia
  • Symptom - Anemia

• Skin
  • Symptom - Bruises
  • Specify - Ecchymosis

• Gastrointestinal System
  • Symptom - Melena
  • Symptom - Bloody vomit

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.

Yes

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

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

On approximately 12Jun2023 the dog developed ecchymosis, melena, and hematemesis. She was taken to a specialty referral clinic and a workup was performed that day, 12Jun2023. This showed severe thrombocytopenia and anemia. A 4DX test was negative, but a tick PCR panel was not performed. The dog was treated, but then due to poor response and prognosis the pet was euthanized on 17Jun2023. A necropsy was not performed and the case is closed.

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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