Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-3802

2. Registrant Information.

Registrant Reference Number: 100045344

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-APR-10

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

06-APR-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 Under 15 lbs

• 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.

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 April 6, 2010 the owner applied the product to the dog, reporting that the orange applicator is for dogs over 60 lbs.

To be determined by Registrant

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

Unknown

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

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

5

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

11. List all symptoms

System

• Respiratory System
  • Symptom - Difficulty Breathing
  • Specify - Abnormal Breathing

• General
  • Symptom - Death

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.

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 April 6, 2010, shortly after the owner applied the product she noticed that the dog started having difficulty breathing, so she took the dog to the veterinarian where diphenhydramine was attempted to be administered. The owner stated the dog died shortly after. The APSS veterinarian stated there is a risk of dermal hypersensitivity and paresthesia, anaphylaxis is possible, but quite rare. The APSS veterinarian recommended having the attending veterinarian call to discuss the case, obtaining additional information, and having a necropsy performed. The owner declined the necropsy as the body was no longer available.

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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