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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-5572

2. Registrant Information.

Registrant Reference Number: 2015TH176

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

Address: 2920 Matheson Blvd E

City: Mississauga

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.

07-JUL-15

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

21-JUN-15

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. 29779      PMRA Submission No.       EPA Registration No.

Product Name: K9 advantix II extra large dog

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

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).

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

lab

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

36.8

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Hives
  • Nervous and Muscular Systems
    • Symptom - Restlessness

12. How long did the symptoms last?

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

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

Fully Recovered / Complètement rétabli

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

A pet owner applied 1 tube of K9 advantix II XL to a 36.8 kg 4 yr old FS lab on June 21 2015 at around 4 PM. At 8 PM the dog seemed restless. June 22 the pet owner noticed hives on the dogs face. The dog was examined and treated with Benadryl June 22 and the dog recovered. The hives were restricted to the dogs head. There were no abnormalities at the application sites. The veterinarian feels an insect bite is more likely. Fuciderm was dispensed to apply to hives as needed.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here