Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7311

2. Registrant Information.

Registrant Reference Number: 130150695

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.

29-OCT-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

21-SEP-13

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. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot Flea And Tick Control For Dogs Over 14 kg

• 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.

2

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 September 20, 2013 the owner applied 2.0 milliliters (mL) of the product to the dog to treat for fleas; the product was used per label. The owner noticed that the dog was able to lick some of the product after the initial exposure to the product. On October 25, 2013 the owner applied 2.0 mL of the product to the dog, but this time he she only applied the product to the base of the neck and did not apply the product to the base of the tail as per the labeled instructions.

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

Australian Cattle Dog Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7.0

7. Weight (provide a range if necessary )

60.0

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Eye
  • Symptom - Glazed eye
  • Specify - Glossy Eyes

• Skin
  • Symptom - Pruritus

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 September 21, 2013 the owner noticed that the dog was symptomatic. The dog had fully recovered on September 22, 2013. About 3 hours after being given another dose of the product on October 25, 2013 the owner noticed that the dog had pruritus. On October 29, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the main concern was for dermal hypersensitivity. The APSS assistant recommended that the owner monitor the dog at home, bathe the dog with liquid dish washing detergent (LDWD), apply vitamin E to the application site, discontinue product usage, call her regular veterinarian to discuss other products that might be used to treat the dog's fleas, 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

Minor

19. Provide supplemental information here

Signs were expected to be mild and self-limiting.