Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6205

2. Registrant Information.

Registrant Reference Number: 140072897

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.

14-JUN-14

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

29-MAY-14

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 May 29, 2014 the owner applied the product onto the dog as treatment.

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

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

15.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Biting
  • Specify - Chewing

• Skin
  • Symptom - Pruritus
  • Symptom - Lesion
  • Specify - Wound
  • Symptom - Hair loss

• General
  • Symptom - Abnormal behaviour
  • Specify - Behavior Change

• Gastrointestinal System
  • Symptom - Weight loss

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

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 May 29, 2014 the dog started vomiting. On June 1, 2014 the dog began chewing and started having pruritus, developed a bloody wound, and alopecia on his hind end. On June 14, 2014 the dog developed a behavior change, so the owner bathed the dog with puppy shampoo. Later that day, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated dermal hypersensitivity reactions and associated behaviors may occur in some dogs. The APSS veterinarian also stated pruritus, alopecia, redness would be expected over application site and the presence of fleas and level of pruritus suggests a flea allergic dermatitis. The APSS veterinarian further stated the owner needs to discuss with regular veterinarian what products may be more effective for this dog. The APSS veterinarian also stated the vomiting may have been due to agent in response to scent, taste, or sensation and delayed signs are more consistent with flea allergic dermatitis (FAD). The APSS assistant recommended taking the dog to the veterinarian, calling back with questions, and calling the veterinarian to ask about flea treatment.

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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 veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On June 22, 2014 an APSS assistant called the owner to obtain an update. The owner stated the dog was still showing signs and she had not taken the dog to the veterinary clinic yet due to financial issues. The APSS veterinarian stated she would not expect the signs to be lasting this far out. She recommended the owner take the dog into the veterinary clinic and provided suggestions to help with finances.