Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0014

2. Registrant Information.

Registrant Reference Number: 140159278

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.

15-DEC-14

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

17-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)

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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 November 15, 2014 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

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

8.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Adipsia
  • Symptom - Abnormal behaviour
  • Specify - Behavior Change

• Eye
  • Symptom - Pupil dilation

• Skin
  • Symptom - Hair loss

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?

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 November 17, 2014 the cat developed anorexia, adipsia, behavior change (burying head in the covers and hiding face), mydriasis, and alopecia. On November 18, 2014 the owner took the cat to the veterinarian and the mydriasis ended. An appetite stimulant (unknown what) was given at an unknown time. On November 20, 2014 the anorexia and adipsia ended. On December 12, 2014 the owner took the cat to the veterinarian when prednisone was given. On December 15, 2014 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated dermal irritation and alopecia can be seen. The APSS assistant recommended having the veterinarian call for information (to discuss case, find out what treatments were done, and how the cat presented to the clinic). The owner stated she was doing online research and believes the product is related to signs. The online reports indicate death and she is afraid the exposure could be fatal. An APSS veterinarian wasn't available to discuss, but did call the owner back to discuss her concerns. The APSS veterinarian stated we would only expect dermal irritation. The APSS veterinarian also stated the cat had improved a lot since November, we would report the findings to the company, but ideally we would like to discuss the case with the attending veterinarian.

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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.