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: 2018-6563

2. Registrant Information.

Registrant Reference Number: 2018CK118

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. 29779      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII extra large 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).

A 12yr mn 40.1kg labrador retriever with history of osteoarthritis (OA) with decreased mobility, obesity, loose stool, chronic allergies (receiving daily prednisone and cetirizine), dental disease, cataract, lenticular sclerosis and multiple subcutaneous masses was treated with 1 tube of k9 advantix II XL on August 28th by the pet 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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever

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?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms


  • Skin
    • Symptom - Hair loss
  • General
    • Symptom - Edema
  • Skin
    • Symptom - Peeling skin
    • Symptom - Other
    • Specify - Hot Spot
    • Symptom - Itchy skin
    • Symptom - Red skin
  • Nervous and Muscular Systems
    • Symptom - Recumbent
  • Gastrointestinal System
    • Symptom - Anorexia
  • Skin
    • Symptom - Dermatitis

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 next day, the dog had red, itchy skin at the application site. Topical vitamin e oil was applied and the dog was bathed with a dish soap. On August 30th, the dog had application site alopecia and was itchier than normal. The dog was examined by a veterinarian and multiple areas of alopecia and scale were identified along the dorsum. Potential diagnoses included a reaction to K9 Advantix II or continued chronic allergic dermatitis. The dog was treated by increasing the daily prednisone dose and treatment with isaderm gel (topical antibiotic/steroid). The clinic notes suggest the owner may also have treated with tea tree oil. the dog improved but on september 6th, the owner reported that hotspots were appearing on other parts of the body. On September 16th, the dog was examined by another veterinary clinic and treated with unknown antibiotics due to alopecia on face, ventrum, dorsum, extremities and generalized itchiness. On September 17th, the owner reported the dog was now inappetent, had peripheral oedema and was recumbent. the owner declined an examination. no further information is expected

To be determined by Registrant

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


19. Provide supplemental information here