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: 2020-2051

2. Registrant Information.

Registrant Reference Number: 33767

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: QUEBEC

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: k9 advantix II 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).

On 15-Jun-2020 a 12.5 year old, 26.8 kg, female spayed Staffordshire Bull Terrier in with a hyperpigmented area 10 cmX 10 cm on the right thorax area located at costo-chondral junction of T4-T5-T6. The hyperpigmented area is very pruritic for the patient when touched. On physical exam, other than hyperpigmentation the skin is normal, on radiographs there is no visible changes or findings was administered one K 9 ADVANTIX II 2 X 4.0 ML EX LGE DOG, (-), by Animal owner. The product was used according to label (Yes).

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

Staffordshire Bull 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 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms


  • General
    • Symptom - Vocalizing
    • Symptom - Discomfort

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

Within 12 hours of application, this causes the dog to vocalise and have discomfort when the hyperpigmented area is touched. This area is not at the site of application of the K9 Advantix II. The outcome is unknown. Please note the dog had the same product applied in Apr-2020 and the dog seemed to get itchier on the hyperpigmented spot after application of the K9 Advantix II. The dog had another application of the product in May-2020 pruritus of that area seemed much worse after the application of the K 9 Advantix II. The patient is being treated with Benadryl 2-3mg/kg three times a day since May 12. This seems to have an improvement of 75% of the pruritus.

To be determined by Registrant

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


19. Provide supplemental information here