Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6021

2. Registrant Information.

Registrant Reference Number: 190124794

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.

17-JUL-19

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

15-JUL-19

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. 31367      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot With Smartshield F&T Control For Dogs Under 30lbs

• 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 July 14, 2019, the owner applied the product to the dog 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

Dog / Chien

3. Breed

Shih Tzu Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5.5

7. Weight (provide a range if necessary )

22.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Skin
  • Symptom - Hair loss
  • Specify - Application Site Alopecia
  • Symptom - Erythema
  • Specify - Application Site Erythema

• General
  • Symptom - Lethargy

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?

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

Sometime on July 15, 2019, the dog developed symptoms. On July 16, 2019, the owner took the dog to the regular veterinarian, who started the dog on diphenhydramine (25 milligrams (mg) twice a day (BID)) and corticosteroid (Surolan topically BID). On July 17, 2019, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that permethrins can cause a tingling sensation to the skin, as well as redness, dermal irritation, and pruritus and that occasionally animals will develop sores or scabs, and alopecia secondary to scratching or biting the application site. The APSS veterinarian also stated that some animals are more sensitive to the ingredients than others, and may experience lethargy, or have an abnormal gait (example (ex.) take a few steps, stop, sit down and turn quickly toward their tail). The APSS veterinarian recommended the owner give the dog a bath (with liquid dish washing detergent (LDWD)), monitor for dermatological signs, and to 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

Signs were expected to be self-limiting.