Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0248

2. Registrant Information.

Registrant Reference Number: 100107210

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.

16-AUG-10

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

12-AUG-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. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea and Tick Control for Dogs Under 14 kg

• 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

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 August 11, 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

Boston Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

21.8

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Erratic Behavior

• General
  • Symptom - Other
  • Specify - Nystagmus
  • Symptom - Other
  • Specify - Fly Biting

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Circling

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Not recovered / Non 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 August 12, 2010 the dog started having erratic behavior, which changed on August 13, and became even more severe on August 14, 2010. The owner then took the dog to the veterinarian, where they bathed the dog three times with liquid dish washing detergent. On August 16, 2010 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated dermal irritation or a contact hypersensitivity may occur following any topical exposure. In addition, the APSS veterinarian stated some animals exhibit abnormal behavior in response to the dermal sensation (paresthesia) that can be associated with topical permethrin . The APSS veterinarian recommended the owner apply Vitamin E and then calling back when they got home. On August 17, 2010 the owner called the APSS back to update the case. The owner stated he was planning on taking the dog to the veterinarian that night and will call back after the appointment. Later on August 17, 2010, after the owner took the dog to the veterinarian, where the attending veterinarian prescribed acepromazine. The APSS veterinarian recommended having a diagnostic evaluation completed, apply Lidocaine to the area of application, have the veterinarian for information, 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

Moderate

19. Provide supplemental information here

The APSS veterinarian recommended taking the dog to the veterinarian and having the veterinarian call for information.