Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0254

2. Registrant Information.

Registrant Reference Number: 100119323

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.

11-SEP-10

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

11-SEP-10

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 8, 2010 the owner sprayed the product onto the cat and continued doing so until September 11, 2010. The cat was heavily saturated with the spray.

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 Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.5

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Shaking
  • Specify - Paw Shaking
  • Symptom - Ataxia

• General
  • Symptom - Lethargy

• Nervous and Muscular Systems
  • Symptom - Disorientation

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

Not recovered / Non rétabli

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 11, 2010 the cat became symptomatic. The owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian recommended monitoring the cat at home for CNS signs, bathing the cat, providing thermoregulation, confining the pet, 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

A few hours after the APSS consultation the owner called the APSS back to update the case. The owner stated the cat was still symptomatic. The APSS veterinarian discussed isopropanol intoxication and stated that the cat will likely take until tomorrow to fully recover. On September 14, 2010 an APSS assistant called the owner to follow up the case. The owner stated the cat is still lethargic, but is eating and able to stand up. The APSS assistant relayed the APSS veterinarian's recommendations to take the cat to the veterinarian, have the veterinarian call for information, and call back with questions. This product was not used according to label directions: Do not use this product more often than once per week.