Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6252

2. Registrant Information.

Registrant Reference Number: 130154579

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.

06-NOV-13

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

06-NOV-13

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. 28743      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On II Flea Control For Cats And Kittens

• Active Ingredient(s)
  • (S)-METHOPRENE

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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 November 6, 2013 the owner applied an unknown amount of the product to the kitten; the owner stated that she did not think that she placed the entire contents of the tube onto the kitten.

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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Mediumhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.42

7. Weight (provide a range if necessary )

6.0

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

• Gastrointestinal System
  • Symptom - Drooling

• General
  • Symptom - Hiding
  • Symptom - Abnormal behaviour
  • Specify - Rolling

12. How long did the symptoms last?

Unknown / Inconnu

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

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 November 6, 2013, immediately after the owner applied the product to the kitten, the owner noticed that the kitten was symptomatic. A short time later that day the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the product contains an insect growth regulator (IGR) and no insecticides. The APSS veterinarian also stated that the signs were consistent with a bad taste reaction if some of the product was licked by the kitten. The APSS assistant recommended that the owner monitor the kitten at home, give a taste treat of 1 teaspoon (tsp) of milk or tuna juice, bathe the kitten with a liquid dish washing detergent (LDWD) if needed (though it was expected that a bath would not be necessary), and call back with questions.

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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

Signs were expected to be mild and self-limiting. Extra Label Use: Used less than labelled dose on kitten.