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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0104

2. Registrant Information.

Registrant Reference Number: 2013CK154

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 77 Belfield Rd

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

16-OCT-13

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

25-AUG-13

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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: K9 Advantix (unknown size)

  • Active Ingredient(s)
    • IMIDACLOPRID
    • 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 approximately 01-Aug-2013, a 10 year old, 17 pound, neutered, male, American Eskimo canine, in good condition, with a concomitant medical condition of fleas, twas administered 1 tube of Advantix (non - US Registered Product) (Imidacloprid - Permethrin) once topically by the owner

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

American eskimo

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

17

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Pruritus

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

Yes

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 approximately 15-Aug-2013, the dog was bathed in a flea and tick shampoo. On approximately 25-Aug-2013, the dog had generalized pruritus and 20-30 fleas were seen on the dog. The dog was bathed in the flea and tick shampoo again on an unknown date in August 2013, on the recommendations of the veterinarian. On approximately 30-Aug-2013, the dog was given a dose of spinosad and the dog recovered on approximately 01-Sep-2013.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

GDS comment:Pruritus is not expected to be generalized but rather linked to the application site, and time to onset is considered too long ( 3 weeks). Sign more likely linked to the flea infestation reported. The observation of fleas on treated animals is not surprising and does not represent the inefficacy of the product against fleas. Fleas must be on the animal to be killed as product has no repellent activity. The number and frequency of of administration of previous application(s) were not reported, therefore, as existing pupae in the enironment may emerge for 6 weeks or longer after treatment is initiated, a reinfestation from the environment is possible, especially if the infestation pressure is high. Thus does not indicate lack of efficacy. Finally, considering all aspects, the case is assessed unlikely