Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-5840

2. Registrant Information.

Registrant Reference Number: 110130086

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.

10-OCT-11

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

02-OCT-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. 2724-497-270

Product Name: Bio Spot Spot On Flea And Tick Control For Dogs For Puppies Toys

• 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.

.034

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 October 1, 2011 the owner inappropriately applied the product to the under age puppy.

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

Pomeranian

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

0.12

7. Weight (provide a range if necessary )

Unknown

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 - Malaise
  • Specify - Unspecified Illness
  • 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 October 2, 2011 the owner noticed that the puppy had an unspecified illness. Later that day, the owner spoke with a veterinary clinic. On October 3, 2011 the puppy died. On October 10, 2011 the owner contacted the company to obtain help. The company's veterinarian stated that the concern was for dermal hypersensitivity and paresthesia, and that severe signs would not be expected. The call center staff recommended that the owner call back with questions on a voicemail.

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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 company's veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected. Label states to not apply product to puppies under 12 weeks of age.