Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7979

2. Registrant Information.

Registrant Reference Number: 2016MA141

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

Address: 2920 matheson BLVD

City: Mississaugua

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.

21-JUL-16

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

19-DEC-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. 29778      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II medium 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.

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 July 20th an owner applied a dose of K9 advantix II for medium dog topically to the dorsal midline of a 6.5kg 7.2yr neutered male poodle. He had received monthly k9 advantix II treatment earlier this year (exact dates unknown) and in 2015 without a problem.

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

poodle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7.2

7. Weight (provide a range if necessary )

6.5

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

• Nervous and Muscular Systems
  • Symptom - Unconsciousness
  • Specify - Loss of consciousness - interpreted to be syncope by veterinarian based on client description

12. How long did the symptoms last?

<=30 min / <=30 min

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 July 20th, 9 hours after treatment the dog lost consciousness (veterinarian believes from the owner's description that it is syncope) and remained recumbent for 10 minutes - the veterinarian interprets this as syncope based on the description given by the owner. The dog is back to normal.

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To be determined by Registrant

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

Major

19. Provide supplemental information here