Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-6279

2. Registrant Information.

Registrant Reference Number: 2017BS014

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.

08-MAY-17

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

03-MAY-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. 29777      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II small 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.

.4

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 5/2/2017 (as directed by his DVM), the caller applied one dose of K9 Advantix II Small Dog between the shoulder blades all in one spot to Mylo a 8 month old, 3.37 kg, m/n Shih Tzu.

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

shih tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

.75

7. Weight (provide a range if necessary )

3.37

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

<=30 min / <=30 min

11. List all symptoms

System

• Skin
  • Symptom - Pruritus
  • Symptom - Other
  • Specify - thickened skin at application site

• General
  • Symptom - Hyperactivity

• Nervous and Muscular Systems
  • Symptom - Depression
  • Specify - depressed
  • Symptom - Agitation

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.

Yes

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

Immediately after application of the K9 Advantix II Small Dog, the owner reports that the dog began scratching and was agitated. On 5/3/2017, the owner notes the application site felt "hard" or thickened and the dog then became depressed/recluse, and would display odd behavior such as staring into the corner. On 5/4/2017, owner reports that the dog would yelp when touched on his back. Owner spoke to his DVM who advised applying Vitamin e oil to the application site, the owner did this without any relief. On 5/5/2017, the dog was taken to the rDVM for treatment. The application site was clipped and cleaned (unknown if full bathing of the pet was completed). Mylo was discharged with a topical ointment only (SeraDerm non- specific). The caller is having a hard time preventing Mylo from scratching at the area. Owner reports that Mylo has not been eating normally since 5/3/2017.

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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