Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6128

2. Registrant Information.

Registrant Reference Number: 140136518

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.

27-OCT-14

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

26-OCT-14

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. 19209      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Shampoo

• Active Ingredient(s)
  • PIPERONYL BUTOXIDE
  • PYRETHRINS

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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.

Unknown

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 October 26, 2014 the owner bathed the dog with the shampoo and then waited until the dog was fully dry before applying the spot on.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Miniature Poodle Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9.0

7. Weight (provide a range if necessary )

11.0

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

• Nervous and Muscular Systems
  • Symptom - Skittish

• General
  • Symptom - Clingy

• Gastrointestinal System
  • Symptom - Loss of appetite

• General
  • Symptom - Abnormal behaviour
  • Specify - Behavior Change
  • Symptom - Hesitancy to move
  • Symptom - Lethargy

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 October 26, 2014 the dog became skittish. On October 27, 2014 the dog became clingy, developed inappetence, a behavior change (more excited than normal), hesitancy to move, and lethargy. Later that day, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated with the shampoo that dermal irritation is possible with any topical exposure and if ingested, mild gastrointestinal (GI) upset may occur. The APSS veterinarian stated in addition, some animals exhibit abnormal behavior in response to the dermal sensation (paresthesia) that may be associated with topical permethrin and if ingested, GI upset and/or a taste reaction may occur. The APSS assistant recommended bathing the dog (wash with liquid dish washing detergent, rinse thoroughly and dry with a towel and keep the pet warm), monitoring the dog home, applying vitamin E, and consulting with a veterinarian (regarding alternate flea control options).

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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