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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-5519

2. Registrant Information.

Registrant Reference Number: 2016RB043

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.

13-SEP-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

12-SEP-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. 29780      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II large dog

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

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).

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

goldnedoodle

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

18.2

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Agitation
  • Skin
    • Symptom - Itchy skin
  • Nervous and Muscular Systems
    • Symptom - Abnormal gait
  • Skin
    • Symptom - Hyperesthesia
    • Specify - skin twitch

12. How long did the symptoms last?

Unknown / Inconnu

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 September 12, 2016 the pet owner applied K9 advantix II large dog to their 18.2 kg, female spayed, 2 year old golden doodle. They have used this product last year and the last few months this year without a problem. When the pet owner returned home after work (the product was applied in the morning of the same day), the dog was agitated and appeared bothered by the most caudal application site, she was trying to scratch at that spot and the skin was twitching. Her gait was also abnormal. The pet owner took the dog to a veterinarian but no medical treatment was performed. The pet owner washed the product off with a detergent shampoo.


To be determined by Registrant

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

Minor

19. Provide supplemental information here