Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0145

2. Registrant Information.

Registrant Reference Number: 100069313

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-JUN-10

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

01-JUN-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. 2724-497-270

Product Name: Bio Spot Spot On Flea and Tick Control for Dogs Puppies Toys Miniature

• Active Ingredient(s)
  • (S)-METHOPRENE
  • PERMETHRIN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.0055

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 June 1, 2010 the owner applied the product onto the dog.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Maltese

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

12

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Agitation

12. How long did the symptoms last?

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

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

Fully Recovered / Complètement rétabli

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 June 1, 2010 the dog became very agitated by the presence of the product, so the owner spot bathed the area with liquid dish washing detergent. Later that afternoon, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian recommended applying Vitamin E to the affected area, monitoring for dermatological signs, using a different flea treatment in the future, bathing the dog if any further reaction, calling the manufacturer to discuss reimbursement questions, 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

Minor

19. Provide supplemental information here

On June 8, 2010 an APSS technician called the owner to follow up the case. The owner stated she had bathed the dog, monitored him, and he had returned to normal on June 1, 2010 after the APSS consultation. The APSS technician again recommended calling the manufacturer for any further reimbursement discussion. This is a U.S. registered product. Formulation is not registered in Canada.