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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-0984

2. Registrant Information.

Registrant Reference Number: 110128421

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.

06-OCT-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

01-OCT-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. 19209      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Shampoo

  • Active Ingredient(s)
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

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

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 October 1, 2011 the owner bathed the dog with the shampoo product to treat for fleas. Approximately 2 hours later, the owner applied the 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

Shih Tzu

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4.0

7. Weight (provide a range if necessary )

11.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Skin
    • Symptom - Dermatitis
    • Symptom - Erythema

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

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 October 1, 2011, shortly after applying the spot on product to the dog, the owner noticed that the dog had symptoms. The owner immediately bathed the dog with hand soap and water. On October 2, 2011 the dog had fully recovered. On October 6, 2011 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the amount of pyrethrins in the shampoo was not expected to cause severe signs, especially after it is rinsed off, and that because the irritation is at the application site the spot on product was responsible for the dog's signs. The APSS veterinarian also stated that permethrins and pyrethroids from the spot on product could cause a tingling sensation to the skin, as well as redness, dermal irritation, and pruritus. The APSS veterinarian said that some animals are more sensitive to the ingredients. 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 72 hours for signs to resolve fully. The APSS assistant recommended that the owner monitor the dog at home, consult with a veterinarian about preventatives, and call back with questions.


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 shampoo product was not considered to be related to causing the clinical situation. The APSS veterinarian stated that the spot on product was considered to have a high likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected.