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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-6453

2. Registrant Information.

Registrant Reference Number: 2016MA212

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.

29-SEP-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

03-AUG-16

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)

PMRA Registration No. 29778      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II medium dog

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

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 and August 31 an owner applied a dose of Advantage multi 20 followed by a dose of k9 advantix II for medium dog three days later, topically over the dorsal midline of an 8.1kg 3yr neutered male Shih Tzu.

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

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

8.1

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

  • Ear
    • Symptom - Ear irritation
  • General
    • Symptom - Hyperactivity
  • Skin
    • Symptom - Pruritus
  • Nervous and Muscular Systems
    • Symptom - Restlessness
  • General
    • Symptom - Vocalizing
    • Specify - growling
    • Symptom - Abnormal behaviour
    • Specify - rolling
    • Symptom - Other
    • Specify - rubbing
  • Ear
    • Symptom - Other
    • Specify - red and thickened ears
  • General
    • Symptom - Licking
  • Nervous and Muscular Systems
    • Symptom - Loss of coordination
    • Specify - falling

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

The day after the K9 advantix II application the dog was restless, growling, rolling/rubbing (itching) at the application site. By September 29th the dog had itchy, red and thickened ears, the dog was licking at its feet, and was falling over to the side. The owner says the dog may have also reacted to advantage multi but did not specify what the reaction was. The veterinarian the feet and ear itching are due to seasonal allergies and prescribed surolan and vanectyl P. The outcome is unknown.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here