Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0027

2. Registrant Information.

Registrant Reference Number: 150109610

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.

11-AUG-15

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

09-AUG-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 August 7, 2015 the owner applied the product onto 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

Parson Russell Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

12.5

7. Weight (provide a range if necessary )

15.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Skin
  • Symptom - Erythema
  • Symptom - Dermatitis

• Gastrointestinal System
  • Symptom - Anorexia

• Skin
  • Symptom - Pruritus
  • Symptom - Lesion
  • Specify - Scab

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

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

On August 9, 2015 the dog developed symptoms. So later that afternoon the owner bathed the dog and applied neomycin polymyxin B and bacitracin ointment onto the application site, the pruritis then ended. On August 10, 2015 the dog developed a scab at the application site. On August 11, 2015 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated the ingredients in this agent have a good margin of safety in dogs. The APSS veterinarian also stated a dermal reaction can be seen in sensitive individuals. The APSS veterinarian finally stated with the dermal lesion resolving would not expect anorexia of this duration. The APSS technician recommended taking the dog to the veterinarian, having the veterinarian call for information, 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

Minor

19. Provide supplemental information here

On August 13, 2015 the owner contacted the APSS and stated that the dog's skin signs have persisted and the crust on the skin is about 1/4 inch thick. The owner wondered if there was anything else she should be doing at home. The APSS veterinarian stated that the crust may be a scab that hasn't fully healed yet or there may be another issue compounding the matter. The APSS veterinarian recommended having the dog checked out by a veterinarian and having the clinic call for further information.