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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6285

2. Registrant Information.

Registrant Reference Number: 2019-US-003526

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

Address: 6-1040 Fountain St. N.

City: Cambridge

Prov / State: Ontario

Country: Canada

Postal Code: N3E 1A3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

08-MAY-19

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW JERSEY

6. Date incident was first observed.

07-MAY-19

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)

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

Product Name:

  • Active Ingredient(s)
    • DINOTEFURAN
      • Guarantee/concentration 4.95 %
    • PERMETHRIN
      • Guarantee/concentration 36.08 %
    • PYRIPROXYFEN
      • Guarantee/concentration .44 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Retriever - Labrador

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

39.916

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Convulsions
  • Gastrointestinal System
    • Symptom - Diarrhea
  • Renal System
    • Symptom - Polyuria
  • General
    • Symptom - Polydipsia
  • Eye
    • Symptom - Decreased pupillary light reflex
    • Specify - Abnormal pupil light reflex
  • General
    • Symptom -
    • Specify - Hypothyroidism
  • Nervous and Muscular Systems
    • Symptom - Unresponsive
  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Recumbent

12. How long did the symptoms last?

Persisted until death

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


To be determined by Registrant

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

Death

19. Provide supplemental information here