Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-7045

2. Registrant Information.

Registrant Reference Number: 170001947

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.

04-JAN-17

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

29-DEC-16

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 December 24, 2016 the owner applied the wrong dose of the product onto the dog to treat condition.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Belgian Sheepdog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7.0

7. Weight (provide a range if necessary )

21.5

kg

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

• Skin
  • Symptom - Hair loss
  • Symptom - Other
  • Specify - Application Site Burn
  • Symptom - Dermatitis

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?

No

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 December 29, 2016 the owner noticed the dog had developed symptoms. Later that day, the owner took the dog to the veterinarian, where the dog's hair was clipped, and supportive care was given (antibiotics and cortisone cream). On January 4, 2017 the owner contacted the Animal Product Safety Service (APSS) to request reimbursement for the vet visit and medications. The owner declined consultation with an APSS veterinarian. The APSS assistant stated permethrins and pyrethroids can cause a tingling sensation to the skin, as well as redness, dermal irritation, and pruritus. The APSS assistant also stated occasionally animals will develop sores or scabs, and alopecia secondary to scratching or biting the application site. The APSS assistant additionally stated some animals are more sensitive to the ingredients than others. The APSS assistant further stated signs often resolve after bathing and with topical applications of vitamin E and cool compresses, but may take up to 24-72 hours. The APSS assistant finally stated s-methoprene is an insect growth regulator (IGR) and primary concerns from topical administration are for mild dermal irritation and redness, usually from the carriers. The APSS assistant recommended referral to the manufacturer (to see if they can help with the cost of treatment) and calling 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 owner used the product inappropriately. Signs are expected to be mild and self-limiting.