Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6034

2. Registrant Information.

Registrant Reference Number: 180206364

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.

11-DEC-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

07-DEC-18

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 December 6, 2018, the owner applied the product to the cat as prevention.

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 Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3.5

7. Weight (provide a range if necessary )

8.0

lbs

8. Route(s) of exposure

Skin

Oral

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
  • Symptom - Loss of appetite
  • Specify - Inappetence

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

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

After the product was applied on December 6, 2018, the cat was able to lick some of the liquid off of his neck. On the morning of December 7, 2018, the cat developed vomiting and a behavior change. The owner stated that the amount of vomit changed by day, ranging from 3-8 times per day. The owner also stated that it is not always a full vomit but varies and that the color changed from white to yellow on December 10, 2018. On December 10, 2018, the cat developed inappetence. On December 11, 2018, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that a taste reaction may be seen and that vomiting for 3 days wouldn't be expected. The APSS veterinarian stated that gastrointestinal (GI) upset is possible in the first 24 hours and that the severity and duration are not consistent with the product. The APSS assistant recommended the owner take the cat to a veterinarian and have the veterinarian call for more information.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. Signs were expected to be mild and self-limiting.