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: 2014-0367

2. Registrant Information.

Registrant Reference Number: 2014CK047

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.


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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: K9 Advantix II(unspecified)

  • Active Ingredient(s)
      • Guarantee/concentration 8.8 %
      • Guarantee/concentration 44 %
      • Guarantee/concentration .44 %

7. b) Type of formulation.


Application Information

8. Product was applied?


9. Application Rate.


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 an unknown date in April 2012, a 10 year old, female, Bichon Frise canine, of unknown weight and reproductive status, in unknown condition, with a concomitant medical condition of unspecified allergies, was administered 1 tube of K9 Advantix II (unspecified) (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

bichon frise

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

<=30 min / <=30 min

11. List all symptoms


  • General
    • Symptom - Death
  • Skin
    • Symptom - Erythema
  • General
    • Symptom - Other
    • Specify - swollen lymph nodes
    • Symptom - Neoplasia

12. How long did the symptoms last?

Unknown / Inconnu

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

On an unknown date in April 2012, the dog the erythema and rolling around resolved.On an unknown date in June 2012, the dog had swollen lymph nodes and was diagnosed with lymphoma and lung cancer. Diagnostics and treatments are unknown.On an unknown date in November 2012, the dog passed away. It is unknown if the dog was euthanized and if a necropsy was performed.Note: The communication was not to report this event, but to discuss a current flea issue.

To be determined by Registrant

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


19. Provide supplemental information here

Behavioural disorder described is very unspecific, however may be a consequence of the uncomfortable feeling caused by the applied product. Would not expect erythema to be generalized but rather linked to the application site. However, considering short time to onset, a dermal sensitivity to the product cannot be excluded. Time to onset for the first course of signs is short. Would not expect death after product application as inconsistent with pharmaco-toxicological product profile. Dog was diagnosed with lymphoma and lung cancer and died most likely due to this medical condition. Time to onset for the second course of signs is very long (3 months). The owner did not call to report an adverse event, but to discuss a current flea issue. Unknown if necropsy was performed. Considering all factors, a product connection is deemed to be unlikely.