Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6232

2. Registrant Information.

Registrant Reference Number: 140045745

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-APR-14

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

17-APR-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. 23075      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Premise Plus Flea Spray

• 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 April 16, 2014 the owner accidentally treated the dog with the product, rather than the flea spray for dogs. The dog was heavily saturated with the product and may have licked some off as well.

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

German Shepherd Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.92

7. Weight (provide a range if necessary )

65.0

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• General
  • Symptom - Lethargy
  • Symptom - Hiding

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Anorexia

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 April 17, 2014 the dog became symptomatic. Later that day, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated can see gastrointestinal (GI) upset if ingested and no problems expected with exposure to dry product. The APSS assistant recommended bathing the dog with liquid dish washing detergent, taking the dog to the veterinarian the next morning, 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

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation.