Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7147

2. Registrant Information.

Registrant Reference Number: 120167766

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-DEC-12

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

04-DEC-12

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. 21206      PMRA Submission No.       EPA Registration No.

Product Name: Vet Kem Ovitrol Plus Flea Spray

• 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 December 4, 2012 the owner sprayed the cat with the product twice and wiped off the excess. The owner did not see the cat lick the product, but the product was in the air and the owner thought that perhaps the cat had inhaled some of the product.

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

Female

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

5.0

kg

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

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 December 4, 2012, just after spraying the cat with the product, the owner noticed that the cat was drooling. The owner immediately contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that oral exposures often cause hypersalivation and retching or vomiting from the taste and that if the product were inhaled, sneezing or coughing could occur; however, severe signs would not be expected. The APSS assistant recommended that the owner monitor the cat at home, give the cat a taste treat, 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.