Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0068

2. Registrant Information.

Registrant Reference Number: 120058362

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.

05-MAY-12

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

01-MAY-12

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. 19209      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Shampoo

• Active Ingredient(s)
  • PIPERONYL BUTOXIDE
  • PYRETHRINS

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PMRA Registration No. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot 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.

Unknown

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 1, 2012 the owner bathed the dog with the flea and tick shampoo product and later applied 1.0 mL of the flea and tick spot on product to 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

Lhasa Apso Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

23.0

lbs

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

Unknown / Inconnu

11. List all symptoms

System

• Skin
  • Symptom - Pruritus

• Nervous and Muscular Systems
  • Symptom - Restlessness
  • Symptom - Anxiety
  • Specify - Distressed
  • Symptom - Head shaking

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Adipsia
  • Symptom - Lethargy

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

Unknown/Inconnu

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 1, 2012 the owner noticed that the dog was symptomatic. On May 2, 2012 the owner took the dog to the veterinarian, where an unknown ear ointment was given to the owner to apply to the dog's ear. On May 3, the owner noticed that the dog's restlessness had become severe, so she took the dog to the veterinarian, where the dog was bathed three times with dog shampoo and given an antihistamine injection. On May 4, 2012 the owner observed that the dog was lethargic. On May 5, 2012 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that dermal irritation could be seen with the flea and tick shampoo product, but that signs would not be expected to last this long, and that with the flea and tick spot on product dermal irritation from the carriers and possible paresthesia-like reactions to permethrin were possible for some individuals. The APSS assistant recommended that the owner bathe the dog with liquid dish washing detergent (LDWD) and rinse with cool water, apply vitamin E to the application site, apply a cold compress, and call 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 stated that the flea and tick shampoo product was considered to have a doubtful likelihood of causing the clinical situation. A follow up was not performed, because signs were expected to be mild and self-limiting. Therefore, the outcome of this case is unknown.