Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-1463

2. Registrant Information.

Registrant Reference Number: 110013439

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.

01-FEB-11

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

01-FEB-11

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. 2724-796-270

Product Name: Adams Flea And Tick Spot On E30 For Medium Dogs 16-30 Lbs

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 3.6 %
  • ETOFENPROX
    • Guarantee/concentration 30 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 5 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

3

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 February 1, 2011, the owner's husband applied the wrong dose of the product to the under labelled aged dog.

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

Chinese Shar pei

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.25

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Loss of appetite
  • Symptom - Diarrhea

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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 February 1, 2011, the owner noticed the dog was vomiting and had no appetite. Later that day, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS technician recommended the owner take the dog to the veterinarian and have the veterinarian call for information, and he also recommended that the owner call back with questions. On February 2, 2011, the owner noticed the dog was still vomiting and refusing to eat, and had also developed diarrhea. Shortly after noticing the dog had diarrhea, the owner contacted the APSS with additional questions and to obtain help. The APSS veterinarian recommended taking the animal to the veterinarian, providing supportive care, 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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not related to the clinical situation. On February 3, 2011, the owner returned the follow-up call to the APSS and stated that the dog was still not eating and had diarrhea, and she planned to take the dog to the veterinarian today. On February 4, 2011, the owner contacted the APSS to state that her dog had died from parvovirus.