Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-5096

2. Registrant Information.

Registrant Reference Number: 110113201

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.

02-SEP-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

28-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)

---

PMRA Registration No. 28743      PMRA Submission No.       EPA Registration No.

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

• Active Ingredient(s)
  • (S)-METHOPRENE

---

PMRA Registration No. 19210      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Breakaway Flea and Tick Collar For Cats

• Active Ingredient(s)
  • PROPOXUR

---

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 20, 2011 the owner applied the spot on product and placed a flea and tick collar on the cat.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Feline Domestic Unspecified

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

14.0

7. Weight (provide a range if necessary )

5.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

• General
  • Symptom - Weakness
  • Symptom - Lethargy
  • Symptom - Hiding
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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

The owner noticed the cat began to experience pruritus, inappetence, and tongue protrusion on August 15, 2011. The owner applied the spot on product to the cat and placed a flea and tick collar on the cat on August 20, 2011. On August 28, 2011 the owner noticed the cat was weak and lethargic, and she had become more inappetent. On September 1, 2011 the owner noticed the cat had become severely lethargic and was hiding. Later that day, the cat died. On September 2, 2011 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that Propoxur is a carbamate that could cause mild dermal irritation, or hypersalivation and nausea if the collar was chewed. The APSS veterinarian also stated that death would not be expected from the exposure. The owner declined a necropsy, and the cat had already been buried on September 1, 2011.

---

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 the substance was not considered to be related to the clinical situation. The APSS veterinarian also stated that anemia was considered to have a medium likelihood of causing the clinical situation. The APSS veterinarian stated that a flea infestation was considered to have a high likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected.