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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-5230

2. Registrant Information.

Registrant Reference Number: 2017MA074

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.

02-JUN-17

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

25-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)

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).

Owner applied a dose of K9 Advantix II for XL large dog topically to an 8yr 37kg dog.

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

German Shepherd

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

37

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Edema
    • Symptom - Pain

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?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Other / Autre

specify Unknown

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On May 24 an owner applied a dose of K9 Advantix II for XL large dog topically to an 8yr 37kg spayed female german Shepherd dog. The following morning the dog was inappetant and had a painful swollen limb. The veterinarian does not think it is related. The outcome is unknown.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

O - Unclassifiable/unassessable Reported swollen limb is not expected as inconsistent with pharmaco-toxicological product profile. Other causes should be considered. Inappetence is very unspecific sign. Reported pain along with inappetence likely associated with reported swollen limb. Though consistent time to onset, a product connection is unassessable.