Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-6357

2. Registrant Information.

Registrant Reference Number: 2015TH195

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

Address: 2920 Matheson Blvd E

City: Mississauga

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.

08-JUL-15

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

08-JUN-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. 29780      PMRA Submission No.       EPA Registration No.

Product Name: K9 advantix II large dog

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN
  • PYRIPROXYFEN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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).

Dose too low

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Border Collie

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.1

7. Weight (provide a range if necessary )

26.6

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

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

11. List all symptoms

System

• Skin
  • Symptom - Itchy skin
  • Symptom - Other
  • Specify - matted hair

• General
  • Symptom - Abnormal behaviour

12. How long did the symptoms last?

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

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

A pet owner applied 1 tube of K9 advantix II large dog to a 13 mo old 26.6 kg M border collie on June 1 2015. The pet owner felt the application of K9 advantix II looked different from previous applications of advantage and advantage multi. On June 8 the pet owner noted the hair at the application site was matted and the dog began experiencing application site itching. The dog was scratching the area and rolling on the ground as well as biting the application site. This lasted approx 17 days. The dog was bathed but no other treatment was given.

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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