Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0863

2. Registrant Information.

Registrant Reference Number: 100162802

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.

20-DEC-10

5. Location of incident.

Country: UNITED STATES

Prov / State: NEBRASKA

6. Date incident was first observed.

10-DEC-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.       PMRA Submission No.       EPA Registration No. 2724-504

Product Name: Zodiac Spot On Plus Flea and Tick Control for Cats Kittens Under 5 Lbs

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 3.6 %
  • ETOFENPROX
    • Guarantee/concentration 40 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Units: mL

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 December 10, 2010 the owner applied the product onto the cat to treat an existing flea infestion.

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

Siamese

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

4

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• General
  • Symptom - Abnormal behaviour
  • Specify - Erratic Behavior
  • Symptom - Pale mucous membrane colour
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

No

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 December 10, 2010 the owner noticed the cat was exhibiting erratic behavior. On December 20, 2010 the cat died and the owner noticed the cat had pale mucous membranes shortly after. The owner then contacted the Animal Product Safety Service (APSS). The APSS veterinarian recommended the owner take the cat's frozen body to the veterinarian and have the veterinarian call form information on the necropsy.

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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 considered to have a doubtful likelihood of causing the clinical situation. According to the gross necropsy report, the results are the cat was in poor nutritional condition and indicates severe iron deficiency anemia. Bone marrow depletion is suggestive of chronic hypo-proliferative anemia. Heart enlargement was also noted which could be idiopathic or secondary to the chronic anemia. Histopathology of the tissues is still pending.