Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7153

2. Registrant Information.

Registrant Reference Number: 130000255

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-JAN-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

31-DEC-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. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot Flea And Tick Control For Dogs Over 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.

2

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 December 30, 2012 the owner applied the wrong dose of product to the dog.

To be determined by Registrant

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

No

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

Female

6. Age (provide a range if necessary )

1.0

7. Weight (provide a range if necessary )

8.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Shaking
  • Symptom - Agitation
  • Specify - Jittery

• Skin
  • Symptom - Pruritus

• General
  • Symptom - Loss of balance
  • Specify - Unsteadiness

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

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

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 December 31, 2012 the owner bathed the dog with a pet shampoo. Later that day, the owner noticed that the dog was symptomatic. On January 1, 2013 the owner noticed that the dog was more jittery; later that evening, the owner noticed that the dog was also unsteady. At an unknown time, the owner applied a cool compress to the dog's face. On the evening of January 1, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the concern was for dermal hypersensitivity and paresthesia. The APSS technician recommended that the owner bathe the dog with a liquid dish washing detergent (LDWD), monitor the dog at home, apply vitamin E to the application site, call back with questions, and take the dog to the veterinarian if signs did not improve within the next 2 hours.

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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 January 3, 2013 the owner contacted the APSS to update the case. The owner stated that soon after speaking with the APSS on January 1, 2013 she bathed the dog with LDWD, applied vitamin E to the application site, and monitored the dog at home. The owner said that later that same evening, the dog had fully recovered. Extra Label Use: used wrong dose of product for size of animal.