Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-6589

2. Registrant Information.

Registrant Reference Number: 2015CK330

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

Address: 2920 matheson BLVD

City: missisaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

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

Domestic Animal

4. Date registrant was first informed of the incident.

20-OCT-15

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

18-OCT-15

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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: k9 advantix (unknown)

• Active Ingredient(s)
  • IMIDACLOPRID
  • 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).

On 18-Oct-2015, a 4 month old, 25 pound, intact, male, Pointer canine, in good condition, with no known concomitant medical conditons, was administered 1 tube of Advantix (non - US Registered Product) (Imidacloprid - Permethrin) orally by the owner. This is an off label use of the product as this product is meant to applied topically.

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

pointer

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.25

7. Weight (provide a range if necessary )

25

lbs

8. Route(s) of exposure

Oral

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

• Respiratory System
  • Symptom - Sneezing

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

Approximately 30 minutes following the off label use of the product, the dog vomited one time.On 19Oct2015 and 20Oct2015, the dog had an episode of reverse sneezing. October 22nd - attempted to contact pet owner for follow-up, no further information has been obtained

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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