Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6238

2. Registrant Information.

Registrant Reference Number: 130163305

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.

26-NOV-13

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

09-NOV-13

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 5 Pounds And Over

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

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.8

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 November 9, 2013 the owner applied the product to the cat to treat for fleas.

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 )

12.5

7. Weight (provide a range if necessary )

6.6

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Loss of appetite

• Liver
  • Symptom - Elevated liver enzymes

• General
  • Symptom - Listless
  • Symptom - Dehydration

12. How long did the symptoms last?

Unknown / Inconnu

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

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 November 9, 2013 the owner noticed that the cat was inappetent after the product had been applied. On November 23, 2013 the owner took the cat to her regular veterinarian, where the cat was monitored and a diagnostic evaluation was done, including a chemistry profile and a complete blood count. The SNAP feline pancreas-specific lipase (fPL) test revealed elevated levels of pancreatic lipase and the cat had elevated alkaline phosphatase. At the clinic that day, the cat was also observed to be listless and dehydrated. On November 26, 2013 the owner's regular veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the ingredients in the product have a good margin of safety in cats. The APSS veterinarian said that the clinical picture provided in this case would not be expected. The APSS veterinarian recommended that the owner's regular veterinarian provide symptomatic care, call for information, and provide additional information regarding the exact name and registration number of the product.

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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. A follow up was not performed, because no significant signs were expected. This product is not registered for use in Canada.