Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-4613

2. Registrant Information.

Registrant Reference Number: 2014TH189

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

Address: 77 Belfield Rd

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

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

Domestic Animal

4. Date registrant was first informed of the incident.

15-JUL-14

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

13-JUL-14

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.

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).

Dose is too large for dog. Pet owner removed 1 ml from container and applied to pet.

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

Cavalier King Charles Spaniel

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

8

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• Skin
  • Symptom - Itchy skin

• General
  • Symptom - Vocalizing
  • Symptom - Hesitancy to move
  • Symptom - Pain

12. How long did the symptoms last?

Unknown / Inconnu

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

On 12-Jul-2014, a 4 year old, 18 pound, intact, female, Cavalier King Charles canine, in good condition, with no known concomitant medical conditions, was administered 1 ml of K9 Advantix II Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. This product is not intended to be administered in this manner. On 13-Jul-2014, the dog exhibited application site pruritus, vocalization, rubbing against furniture (pruritus), and not wanting to move (behavioral). On 14-Jul-2014, the dog presented to the veterinarian for an examination. Radiographs were performed with no known abnormalities. The dog was treated for a possible soft tissue injury/pain and prescribed liquid carprofen by mouth and tramadol by mouth. On 15-Jul-2014, the clinical signs were ongoing with no change. The dog was then bathed in a liquid dish soap and vitamin E oil was applied to the application site and the clinical signs decreased for approximately 10 minutes before reoccurring.

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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