Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6289

2. Registrant Information.

Registrant Reference Number: 140149821

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.

25-NOV-14

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

23-NOV-14

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. 19209      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Shampoo

• Active Ingredient(s)
  • PIPERONYL BUTOXIDE
  • PYRETHRINS

---

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 November 23, 2014 the owner used the shampoo on the cat to treat an existing flea problem. The owner let the product sit on the cat for 10 minutes, then rinsed.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Himalayan

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Respiratory System
  • Symptom - Coughing

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • 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 November 23, 2014 the cat was symptomatic. Shortly after, the owner found the cat dead. The body was then buried after the owner contacted an emergency veterinary clinic and was told the product was the cause. On November 25, 2014 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated the ingredients in this agent have a good margin of safety in cats. The APSS veterinarian stated drooling as a taste reaction can be seen, but death would not be expected. The APSS veterinarian finally stated would suspect the death was from an underlying health issue such as cardiomyopathy. The APSS technician discussed the role of the APSS and stated a necropsy was not available. The APSS technician recommended calling back with questions (with more medical questions) and referred to the manufacturer (to discuss concerns and potential litigation).

---

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. On November 25, 2014 the owner called the APSS back to provide the lot number of the product involved. On November 26, 2014 the owner called the APSS to ask for phone numbers for the Zodiac product and to ask who and what the APSS does for the company. The APSS veterinarian provided the phone numbers and discussed the APSS and relayed to the owner all records will be sent to the manufacturer.