Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6973

2. Registrant Information.

Registrant Reference Number: 2013CK104

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.

06-DEC-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

26-NOV-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)

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PMRA Registration No. 27581      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II (small dog)

• Active Ingredient(s)
  • IMIDACLOPRID
  • PYRIPROXYFEN

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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).

Advantage II (small dog) was applied at a veterinary clinic on November 25th, 2013 in one location on the back of the neck to 'Jazz", a 2 year old (5lb) pure bred European maltese 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

European Maltese

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

2.3

kg

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

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

11. List all symptoms

System

• Skin
  • Symptom - Pruritus

• General
  • Symptom - Lethargy

• Skin
  • Symptom - Erythema

• General
  • Symptom - Adipsia

• Gastrointestinal System
  • Symptom - Anorexia
  • Symptom - Loss of appetite
  • Specify - innapetent

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.

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

November 26th, the dog appeared lethargic and was inappetent and not drinking. A couple of days after application, the dogs legs appeared pinker than normal, and the dog felt warmer than normal. The dog also began chewing its feet intensely for 3-4 days. The owner reported that the dog was fully recovered by December 3rd (1 week after initial application).

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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

Jazz was bathed with a flea bath shampoo (unknown brand) obtained from a pet store on November 24th.