Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4442

2. Registrant Information.

Registrant Reference Number: 080085628

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.

03-AUG-08

5. Location of incident.

Country: UNITED STATES

Prov / State: GEORGIA

6. Date incident was first observed.

02-AUG-08

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)

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-488

Product Name: Zodiac Spot On Flea Control For Cats And Kittens

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 3.6 %

---

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: Drop

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 2, 2008, the owner applied one drop of the product to a kitten as a form of treatment.

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

Female

6. Age (provide a range if necessary )

0.12

7. Weight (provide a range if necessary )

0.40

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Pale mucous membrane colour

• Nervous and Muscular Systems
  • Symptom - Recumbent

• General
  • Symptom - Hypothermia

• Respiratory System
  • Symptom - Tachypnea

• General
  • Symptom - Lethargy
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

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 3, 2008, the animal presented to the local veterinary clinic. The attending veterinarian placed the animal on oxygen and attempted to warm her. The APSS veterinarian as well as the attending veterinarian speculated that the animal was suffering from a severe anemia situation given the animal's severe flea infestation and the paleness of her mucous membranes. The APSS veterinarian recommended the attending veterinarian provide the animal with symptomatic and supportive care.

---

To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

The APSS veterinarian stated that this substance was not related to the clinical situation but was related to the severity of the flea anemia. On August 8, 2008, the APSS received an update from the veterinary clinic. The attending veterinarian gave subcutaneous fluids, a dewormer, and a flea adulticide to the kitten. The owner declined hospitalization. Despite the attending veterinarian's efforts, the kitten died on August 3, 2008. This product was not used according to label direction. Do not use on kittens under 12 weeks of age.