Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0082

2. Registrant Information.

Registrant Reference Number: 150045684

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.

10-APR-15

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

09-APR-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. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot Flea And Tick Control For Dogs Under 14 kg (30 lbs)

• Active Ingredient(s)
  • (S)-METHOPRENE
  • PERMETHRIN

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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 April 2, 2015 the owner applied the product onto the dog.

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

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8.0

7. Weight (provide a range if necessary )

10.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Eye
  • Symptom - Edema
  • Symptom - Other
  • Specify - Blinking
  • Symptom - Squinting
  • Symptom - Discharge eye
  • Symptom - Irritated eye
  • Specify - Rubbing Eyes

12. How long did the symptoms last?

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

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

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 April 9, 2015 the dog developed symptoms. Later that day, the owner gave 1 milliliter of diphenhydramine. On April 10, 2015 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated ocular irritation would only be expected if the freshly applied product got into the dog's eyes. The owner also stated she had recently switched the dog's food. The APSS assistant recommended the owner take the dog to the veterinarian, have the veterinarian call for information, and call back with questions.

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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 not considered to be related to causing the clinical situation. On April 15, 2015 an APSS technician called the owner to follow up on the case. The owner stated that she took the dog to the veterinarian on April 10, 2015 where symptomatic care of seasonal allergy and food allergy treatment was done. The owner further stated the dog had fully recovered on April 13, 2015, but she was still giving the dog Benadryl.