Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0209

2. Registrant Information.

Registrant Reference Number: 160001787

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G5L3

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

Domestic Animal

4. Date registrant was first informed of the incident.

04-JAN-16

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

04-JAN-16

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. 21744      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Spray For Dogs and Cats

• Active Ingredient(s)
  • (S)-METHOPRENE
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
  • PIPERONYL BUTOXIDE
  • PYRETHRINS

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7. b) Type of formulation.

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).

On January 4, 2016 the owner sprayed the cat with the product.

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

Cat / Chat

3. Breed

Feline Domestic Unspecified

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3.0

7. Weight (provide a range if necessary )

8.0

lbs

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 / <=30 min

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Ataxia

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Loss of appetite

• General
  • Symptom - Adipsia
  • Symptom - Vocalizing

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

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

On January 4, 2016 the cat developed symptoms. Shortly after the owner rinsed the cat's coat/skin. An hour later the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated the ingredients in this product have a good margin of safety in cats. The APSS veterinarian also stated can see a decrease in appetite, behavior changes and possible ataxia as adverse events; but those signs can be caused by other things as well. The APSS assistant recommended the owner take the cat to the veterinarian (to see if something else is going on; sometimes other health concerns can display when cats are stressed) and having the veterinarian call for information. The owner stated she did not want to go into a clinic at this point. The APSS assistant recommended bathing the cat (as little stress as possible during), monitoring the cat at home, taking the cat to the veterinarian (if signs persist or worsen), having the veterinarian call for information, and calling back with questions.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here