Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7149

2. Registrant Information.

Registrant Reference Number: 120170737

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.

11-DEC-12

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

08-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. 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.

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).

Sometime between December 7 and December 8, 2012 the owner applied the product to the dog to prevent fleas.

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

Bichon Frise

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8.5

7. Weight (provide a range if necessary )

14.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Skin
  • Symptom - Pruritus

• General
  • Symptom - Vocalizing

• Nervous and Muscular Systems
  • Symptom - Agitation

• Skin
  • Symptom - Lesion
  • Specify - Scab
  • Symptom - Erythema

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

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 December 8, 2012, at an unknown time after the owner applied the product to the dog, the owner noticed that the dog was symptomatic. As soon as the owner observed the dog's signs, she bathed the dog with Dove soap. Later that evening, the owner noticed that the dog had scabs and erythema, so she clipped some of the fur away at the application site to help ease the pulling by the scabs and applied a warm compress to the site (and continued doing this daily). On the evening of December 9, 2012 the owner placed a T-shirt on the dog to keep him from scratching. On the morning of December 11, 2012, the owner noticed that the dog's pruritus was milder and that the dog was no longer agitated. A short time later that morning, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS assistant stated that some individuals may have a paresthesia or hypersensitivity reaction to some spot on products and that the sensation may last 2 to 3 days post exposure. The APSS assistant also stated that severe signs would not be expected. The APSS assistant recommended that the owner bathe the dog with liquid dish washing detergent (LDWD), apply vitamin E to the application site, apply a cold compress, discontinue product usage, take the dog to the veterinarian if the signs did not resolve, 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

Minor

19. Provide supplemental information here

Signs were expected to be mild and self-limiting.