Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0770

2. Registrant Information.

Registrant Reference Number: 100124839

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.

24-SEP-10

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

23-SEP-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. 28743      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On II Flea Control for Cats and Kittens

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

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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 September 22, 2010 the owner applied the product onto 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

Male

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Ataxia
  • Symptom - Muscle tremors

• Gastrointestinal System
  • Symptom - Bloody vomit

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown/Inconnu

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 September 23, 2010 the cat started vomiting, tremoring, and was ataxic. The owner then took the cat to the veterinarian, where fluid therapy, diazepam, and phenobarbital were given. The owner then used a translation service to contact the Animal Product Safety Service (APSS), the attending veterinarian then discussed the case with the APSS. The APSS veterinarian stated at most dermal reactions are possible. The APSS veterinarian recommended the attending veterinarian give the cat methocarbamol to control the tremors, call back with questions, and have hair testing done.

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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

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On October 5, 2010 an APSS technician contacted the attending veterinary clinic to follow up the case. The attending veterinarian stated that the hair testing sample had been submitted. On October 6, 2010 the owner contacted the APSS to update the case using a translator. The owner stated the cat is better, but she wanted the address for the hair sample. The APSS veterinarian stated the attending veterinarian should have all of the directions and the address for submittal of the hair. On October 18, 2010 the hair testing results showed the hair sample contained permethrin and etofenprox (etofenprox is not registered in Canada), but no methoprene, indicating the cat was not treated with the Zodiac Spot On II Flea Control for Cats and Kittens.