Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7184

2. Registrant Information.

Registrant Reference Number: 130040683

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.

31-MAR-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

31-MAR-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.

1

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).

On March 31, 2012 the owner applied the product to the cat to treat for fleas.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Scottish Fold

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.0

7. Weight (provide a range if necessary )

7.0

lbs

8. Route(s) of exposure

Skin

Oral

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

• Gastrointestinal System
  • Symptom - Drooling

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 the evening of March 31, 2013 the owner noticed that the cat was drooling. The owner immediately gave the cat some water, and the episode of drooling ended. Later that evening the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the pet was exhibiting signs of a taste reaction and that other signs that could develop include dermal hypersensitivity reactions, ataxia, lethargy, and vomiting. The APSS assistant recommended that the owner give the cat a taste treat of canned food or 1/8 to 1/4 cup of milk, tuna, tuna juice, or chicken broth 1 time by mouth; bathe the cat with a liquid dish washing detergent (LDWD) if the cat began drooling again; monitor the cat for gastrointestinal (GI) signs of drooling and vomiting; manage any vomiting by giving nothing by mouth for 2 hours and then gradually reintroducing water and then food; 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

The APSS veterinarian stated that the substance was considered to have a high likelihood of causing the clinical situation. A follow up was not performed, because signs were expected to be mild and self-limiting. Therefore, the outcome of this case is unknown.