Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-0770

2. Registrant Information.

Registrant Reference Number: 180190004

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.

13-NOV-18

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

01-NOV-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.       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
    • Guarantee/concentration 3.6 %
  • ETOFENPROX
    • Guarantee/concentration 40 %

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7. b) Type of formulation.

Liquid

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 October 29, 2018, the owner applied this product to the cat to treat a condition.

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

Male

6. Age (provide a range if necessary )

6.0

7. Weight (provide a range if necessary )

12.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

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

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Anorexia

• 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

Sometime between October 31, 2018 and November 2, 2018, the cat developed a behavioral change and vomiting. On November 2, 2018, the owner contacted the regular veterinarian who recommended bathing the cat. The owner then bathed the cat with Dawn dish washing liquid (DDWL) several times. Sometime between November 6, 2018 and November 8, 2018, the cat developed anorexia. On November 13, 2018, the cat passed away. The owner then contacted the Animal Product Safety Service (APSS) to report the death. The APSS veterinarian stated that no systemic toxicity is expected. The APSS assistant recommended the owner call back with questions.

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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 not considered to be related to causing the clinical situation. The owner stated they did not want a necropsy and that the cat would be buried.