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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-0108

2. Registrant Information.

Registrant Reference Number: 110111385

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.

29-AUG-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

29-AUG-11

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)

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

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 August 15, 2011 the owner applied the product to the dog to treat for 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

Border Collie Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

9.0

7. Weight (provide a range if necessary )

74.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Hair loss
    • Symptom - Dermatitis
    • Symptom - Other
    • Specify - Prurulent Discharge
    • Symptom - Lesion
    • Symptom - Pruritus

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 August 22, 2011 and again on August 29, 2011 the owner decontaminated the environment to treat for fleas. On August 29, 2011 the owner noticed the dog was losing hair above the tail, in an area about the size of an egg. The owner also noticed that the dog had additional dermal symptoms. After noticing the signs, the owner decontaminated the skin using, hydrogen peroxide to clean the area, and applied a Polymyxin B Bacitracin ointment to the area. Shortly after, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that permethrins and pyrethroids can cause a tingling sensation to the skin, as well as redness, dermal irritation, and pruritus. The APSS veterinarian also stated that occasionally animals will develop sores or scabs, and alopecia. She further stated that some animals are more sensitive to the ingredients than others, and may experience rolling, hiding, vocalization, clingy behavior, lethargy, reluctance to move, or have an abnormal gait. The APSS veterinarian stated that signs often resolve after bathing and with topical applications of vitamin E and cool compresses, but it could take up to 24 to 74 hours. The APSS veterinarian suspected that the dog had a hot spot secondary to scratching or biting, possibly from fleas or from the tingling from the product. The APSS assistant recommended that the owner take the dog to the veterinarian, have the veterinarian call for information, consult with the veterinarian about another method of flea control, call back with questions, discuss a refund with the product manufacturer, and decontaminate the environment.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Minor

19. Provide supplemental information here