Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-0087

2. Registrant Information.

Registrant Reference Number: 110054921

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.

06-MAY-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

06-MAY-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 Small Dogs 13-31 Lbs

• Active Ingredient(s)
  • (S)-METHOPRENE
  • ETOFENPROX
  • PIPERONYL BUTOXIDE

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7. b) Type of formulation.

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 May 5, 2011 the owner's husband inappropriately applied the product to the under label 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

German Shepherd Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.31

7. Weight (provide a range if necessary )

20.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Eye
  • Symptom - Bloodshot eye

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 May 6, 2011 the owner noticed the dog was symptomatic. Later that evening, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that problems were not expected even though the dog was four months old. The APSS veterinarian also stated that ocular effects were not expected unless the agent got in the dog's eyes.

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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 assistant recommended that the owner bathe the dog with liquid dish washing detergent, monitor the dog at home for red eyes and itchy, red skin, take the dog to the veterinarian if the red eyes persisted, and to call back with questions. A follow up was not performed, because signs were expected to be mild and self-limiting. Therefore, the outcome of this case is unknown. Product was used on dog which was under label age.