Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-0021

2. Registrant Information.

Registrant Reference Number: 110105002

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.

14-AUG-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

14-AUG-11

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. 19209      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Shampoo

• Active Ingredient(s)
  • 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 August 14, 2011 the owner bathed the cat with the shampoo.

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

Animal's Owner

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 )

9.0

7. Weight (provide a range if necessary )

15.0

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 <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Inappropriate defecation

• Renal System
  • Symptom - Inappropriate urination

• General
  • Symptom - Lethargy

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

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 August 14, 2011 the owner noticed the cat was symptomatic. Later that afternoon the owner noticed the cat was lethargic. Shortly after the cat became lethargic, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that signs were not expected from a shampoo and that the shampooing process may have stressed the cat out, resulting in signs. The APSS assistant recommended that the owner monitor the cat at home, call back with questions, and take the cat to the veterinarian if there was no improvement.

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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

On August 18, 2011 an APSS assistant called the owner to update the case. The owner stated that she continued to monitor the cat at home, and on the morning of August 15, 2011 she took the cat to the veterinarian, where a chemistry profile was performed and the results were within normal limits. By the evening of August 18, 2011, when the APSS assistant called the owner, the cat's signs continued, but they were much improved.