Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7272

2. Registrant Information.

Registrant Reference Number: 130128958

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.

13-SEP-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

Unknown

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. 28382      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Dual Action Flea And Tick Spray For Cats And Kittens

• 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 September 5, 2013 the owner sprayed the cat with an unknown amount of the product to treat for fleas. On September 9, 2013 the owner applied an unknown spot on flea product to the cat.

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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4.0

7. Weight (provide a range if necessary )

6.47

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Adipsia
  • Symptom - Hyperthermia

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 September 9 or 10, 2013 the owner noticed that the cat was symptomatic. On September 11, 2013 the owner bathed the cat with water only, which was ineffective. On September 13, 2013 the owner's regular veterinarian observed that the cat was hyperthermic. A short time later that day the owner's regular veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the risk with the spray product was for mild, self-limiting gastrointestinal (GI) upset. The APSS veterinarian also stated that because the identity of the spot on product was unknown the risk was unknown, and that even if a permethrin product had been applied more significant signs would be expected by that point in time. The APSS veterinarian recommended that the owner's regular veterinarian perform a diagnostic evaluation, provide symptomatic and supportive care, 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 spray product was not considered to be related to causing the clinical situation.