Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-3589

2. Registrant Information.

Registrant Reference Number: 120045830

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.

12-APR-12

5. Location of incident.

Country: UNITED STATES

Prov / State: KANSAS

6. Date incident was first observed.

06-APR-12

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.       PMRA Submission No.       EPA Registration No. 2724-497-270

Product Name: Bio Spot Spot On Flea And Tick Control For Dogs Large Size Dogs

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 3 %
  • PERMETHRIN
    • Guarantee/concentration 45 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.101

Units: oz (fl) / oz (liquide)

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 3, 2012 the owner inappropriately applied the product to the dog to treat for fleas.

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

Canine Domestic Unspecified

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7.5

7. Weight (provide a range if necessary )

20.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Lethargy
  • Symptom - Polydipsia

• Gastrointestinal System
  • Symptom - Loss of appetite

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

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 6, 2012 the owner noticed that the dog was lethargic. On April 7, 2012 the owner observed that the dog had also become polydipsic and inappetent, eating table food but not dog food or treats; the owner then gave 3 cubic centimeters (cc) of penicillin to the dog to try to treat the symptoms. On April 12, 2012 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS assistant recommended that the owner take the dog to the veterinarian, have the veterinarian call for information, 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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to the clinical situation. On April 19, 2012 an APSS assistant called the owner to update the case. The owner stated that he had monitored the pet at home at an unknown date and time and that he did not take the dog to the veterinarian. The owner said that the dog died on April 15, 2012. A necropsy was not available. Label states to use only dogs 30 lbs and over.