Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-8170

2. Registrant Information.

Registrant Reference Number: 2017CP375

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.

23-NOV-17

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

21-NOV-17

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. 27582      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II Large 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.

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).

On November 18 2017 , a 23 kg, 3 year old male neutered canine Australian shepherd with no concomitant medical condition , was applied one tube K9advantixII large dog once topically by the owner.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Australian Shepherd Dog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

23

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Seizure

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

Unknown/Inconnu

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 November 18 2017 , a 23 kg, 3 year old male neutered canine Australian shepherd with no concomitant medical condition , was applied one tube K9advantixII large dog once topically by the owner; three days after application, the dog had one seizure, that lasted one minute , Note: Previous application were well tolerated.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here

N - Unlikely It is known that, at recommended dosage, none of active ingredients in the product have the potential to provoke seizures in dogs neither alone nor in combination. Only mild neurological signs, e.g. tremors or ataxia, may occur even after licking. Dog tolerated previous applications well, without neurological signs. Time to onset is rather long ( 3 days). Other causes more probable. Consistent all aspects, a product relation is deemed to be unlikely.