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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-5882

2. Registrant Information.

Registrant Reference Number: 2018CK084

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.

20-JUL-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

08-JUL-18

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. 29777      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII small 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).

21month old 4.1kg fs cross breed dog was treated with 1 tube of k9 advantix II small dog on july 8th.

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

Crossbred

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.75

7. Weight (provide a range if necessary )

4.1

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

  • Skin
    • Symptom - Pruritus
  • General
    • Symptom - Discomfort
  • Nervous and Muscular Systems
    • Symptom - Restlessness

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

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

within 12 hrs the dog was itching at the application site. the dog was uncomfortable and restless for approximately 1 week. no treatment was required


To be determined by Registrant

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

Minor

19. Provide supplemental information here

B - Possible Reported itching at the application site and restless may reflect paresthesia caused by permethrin. Uncomfortable behavior is unspecific, however may be a consequence of reported paresthesia. Considering consistent time to onset and application site involvement, a product connection is deemed to be possible.