Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7642

2. Registrant Information.

Registrant Reference Number: 2016MA051

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.

26-MAY-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

20-MAY-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).

On May 20th an owner applied a dose of K9 advantix II for large dog topically in several spots over the dorsal midline of a 23 pound 9 yr spayed female cock-a-poo.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

Cock-a-poo

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

23

lbs

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • General
    • Symptom - Hyperactivity
  • Skin
    • Symptom - Paresthesia
    • Symptom - Itchy skin
  • Gastrointestinal System
    • Symptom - Bloody diarrhea
    • Symptom - Loss of appetite

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

Died

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 the day of application the dog developed paresthesia at the application site and was itchy and agitated. This resolved completely over the following few days with mild improvement seen after vitamin E application. Several days after resolution of those signs the dog presented to the veterinarian for bloody diarrhea and inappetance but the veterinarian believes this is likely a pathogen (not related to K9 advantix) going through the local dog community.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here