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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6130

2. Registrant Information.

Registrant Reference Number: 2018TH099

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.


5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

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. 29778      PMRA Submission No.       EPA Registration No.

Product Name: K9 AdvantixII medium 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 June 15 2018 a pet owner applied 1 tube of K9 advantix II med dog to a 7.4 kg 4 yr old MN rat terrier.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Rat 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?

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

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms


  • Skin
    • Symptom - Itchy skin
  • Gastrointestinal System
    • Symptom - Vomiting

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

The dog experienced localized itching of the axilla beginning the same day. The dog does have pre-existing allergies with the same symptoms for which it is treated with prednisone, apoquel and cortivance. June 18 the dog was bathed. June 20 the clinic was contacted and recommended vitamin E. The owner did not give vitamin E. June 21 the pet was examined. A skin scraping conducted that day was negative. June 21 the dog was also itchy at the application site. The dog was sent home with refills for medication for pre-existing coniditions and fortiflora for pre-exisitng GI issues/inappetance. The dog vomited June 22.

To be determined by Registrant

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


19. Provide supplemental information here

O-Unassessable: Reported itching is not expected to be localized on the axilla but rather be linked to the application site. Other causes should be considered. Application site itching may reflects discomfort caused by the applied product. Later reported vomiting is unspecific sign and may have multiple potential causes. Potential oral exposure was not reported. Though time to onset is consistent for initial reported signs, it is long (7 days) for later reported sign. Considering overall aspects, a product connection is unassesssable.