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: 2014-0105

2. Registrant Information.

Registrant Reference Number: 2013CK155

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

Address: 77 Belfield Rd

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.


5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.


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.


PMRA Registration No. 29777      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix II (small dog)

  • Active Ingredient(s)

7. b) Type of formulation.

Application Information

8. Product was applied?


9. Application Rate.


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 approximately 01Oct2012, unknown old, 4 pound, spayed, female, Yorkshire Terrier canine, in unknown condition with no known concomitant medical conditions was administered 1 tube of an unknown size of Non-US Advocate (imidacloprid and moxidectin) once topically by the owner. The product has not been used since this application. Approximately a year later on 24Sept2013, the dog had puritus and dandruff. On 07-Oct-2013, the dog was administered 1 tube of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) once topically by the owner.

To be determined by Registrant

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


Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Yorkshire Terrier

4. Number of animals affected


5. Sex


6. Age (provide a range if necessary )


7. Weight (provide a range if necessary )



8. Route(s) of exposure


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


  • Skin
    • Symptom - Pruritus
    • Symptom - Dry skin
  • General
    • Symptom - Abnormal behaviour
    • Specify - dog started pulling its hair out

12. How long did the symptoms last?

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

13. Was medical treatment provided? Provide details in question 17.


14. a) Was the animal hospitalized?


14. b) How long was the animal hospitalized?

15. Outcome of the incident


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

The pruritus resolved after the application of K9 Advantix II Small dog but the dandruff continued.On 09Oct2013, the pruritus returned and the dog started pulling it's hair out (behavorial).On 12Oct2013 the owner bathed the dog with an oatmeal shampoo and reapplied a partial amount of K9 Advantix II small dog on 17Oct2013 and the clinical signs continued.

To be determined by Registrant

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


19. Provide supplemental information here

GDS comment: Generalised skin reactions are not expected after product use. If any, signs would be located at the application site. Onset time not indicative for product involvement either, as too long (1 year). Other causes seem more likely, e.g. allergies or parasites. Reported behavioural changes are unspecific, but likely linked to pruritus. Considering all aspects, a product connection seems unlikely.