Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-3100

2. Registrant Information.

Registrant Reference Number: 160003182

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.

07-JAN-16

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

31-DEC-15

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. 1021-2684-89459

Product Name: Zodiac Flea And Tick Dip For Dogs And Cats Quick Kill Alcohol Free

• Active Ingredient(s)
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 3 %
  • PYRETHRINS
    • Guarantee/concentration .3 %

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7. b) Type of formulation.

Liquid

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 December 29, 2015 the owner noticed the cat had a flea infestation and was lethargic. On December 31, 2015 the owner used the product per the company's instructions (he had spoken with the company prior to use and was told to not rinse off the product after the dip).

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

Domestic Mediumhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10.0

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Unresponsive

• Eye
  • Symptom - Pupil dilation

• General
  • Symptom - Pale mucous membrane colour

• Eye
  • Symptom - Decreased pupillary light reflex
  • Specify - Absent Pupillary Light Reflex

• 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 December 31, 2015 within a couple minutes of the dip, the cat became unresponsive and had developed symptoms. Shortly after, the cat died. On January 7, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated this product has a low concentration of pyrethroids. The APSS veterinarian recommended a necropsy, but the owner stated the cat's body had been buried for 7 days, so that was unavailable. The APSS veterinarian stated that she would not expect the product alone to cause an acute death like this and she suspects an underlying condition (heart disease, anemia, etc) and the stress of the treatment may have ultimately contributed to her death. The APSS veterinarian assured the owner that the event would be reported to the company. The owner requested the contact number for the Environmental Protection Agency (EPA). The APSS veterinarian gave the owner the National Pesticide Information Center (NPIC) hotline number and encouraged the owner to contact the manufacturer to discuss history of similar events.

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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 considered to have a doubtful likelihood of causing the clinical situation.