Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-2406

2. Registrant Information.

Registrant Reference Number: 100030201

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.

13-MAR-10

5. Location of incident.

Country: UNITED STATES

Prov / State: GEORGIA

6. Date incident was first observed.

12-MAR-10

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 Extra Large Dogs 81-150 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.

9

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 March 11, 2010 the owner applied the wrong dosed product to the 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

Canine Domestic Unspecified

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

22

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

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 - Death

12. How long did the symptoms last?

Persisted until death

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

Yes

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 March 12, 2010 the owner noticed the dog's behavior had changed, and on March 13, 2010 the dog was laying around. The owner took the dog to the veterinarian where they gave subcutaneous fluids and sent the dog home with instructions for the owner to bathe the dog and then give the oral antibiotics. On March 13, 2010 the APSS veterinarian stated we normally would not expect to see anything beyond a dermal hypersensitivity reaction with this exposure. The APSS veterinarian recommended having the veterinarian call for information.

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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

On March 16, 2010 an APSS technician contacted the owner to follow up the case. The owner stated that the dog died following the APSS consultation on March 14, 2010. This product was not used according to label directions: wrong dose of product used on dog. According to the APSS veterinarian, the product had doubtful likelihood of causing the situation.