Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-0043

2. Registrant Information.

Registrant Reference Number: 110082119

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.

30-JUN-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

29-JUN-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

---

7. b) Type of formulation.

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 June 28, 2011 the owner applied the product to her cat. Testing revealed the cat was also exposed to Permethrin, possibly due to dog being treated with unknown topical.

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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.46

7. Weight (provide a range if necessary )

6.4

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Fasciculations
  • Symptom - Trembling

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Fully Recovered / Complètement 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 June 29, 2011 the owner noticed the cat was symptomatic. Later that evening, the owner bathed the cat. On the morning of June 30, 2011 the owner took the cat to the veterinarian, and the veterinarian contacted the Animal Product Safety Service (APSS) to obtain help shortly after the cat arrived. The APSS veterinarian stated that Methoprene is an insect growth regulator (IGR) with a very wide margin of safety and that the signs the cat was having would not be expected from the use of the product. The APSS veterinarian discussed the possibility that the cat was inadvertently exposed to Permethrin from another product. The APSS veterinarian recommended that the veterinarian obtain additional information about the product placed on the cat, provide Methocarbamol by injection and send oral Methocarbamol home with the owner, and to call back with questions.

---

To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On the morning of June 30, 2011 the APSS veterinarian called the regular veterinarian to discuss having hair testing done to test for Permethrin, Etofenprox, and Methoprene. On July 5, 2011 an APSS veterinarian called the regular veterinarian, who stated that on June 30, 2011 the cat was given fluid therapy and, as instructed, was given an injection of Methocarbamol and was sent home with oral Methocarbamol. The regular veterinarian stated that the cat had fully recovered by the evening of June 30, 2011. The regular veterinarian also confirmed that they were having hair testing done. On July 18, 2011 the results of the hair testing were available. The hair testing confirmed the cat was exposed to Permethrin and Methoprene, but not to Etofenprox. On July 21, 2011 the APSS veterinarian called the regular veterinarian's staff to discuss the hair testing results and to request that the regular veterinarian share the information with the owner.