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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-3625

2. Registrant Information.

Registrant Reference Number: 2018RB074

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


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: Advantix Plus Spot-on pipette size unknown

  • Active Ingredient(s)

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 the pet owner applied an unknown dose of K9 Advantix II to their 8 year old Springer Spaniel

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

springer spaniel

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

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

11. List all symptoms


  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea
  • General
    • Symptom - Jaundice
    • Symptom - Lethargy
  • Blood
    • Symptom - Anemia
    • Symptom - Leukocytosis
    • Symptom - Thrombocytopenia
  • Gastrointestinal System
    • Symptom -
    • Specify - ascites
  • Blood
    • Symptom - Hypoproteinemia

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

Euthanised / Euthanasie

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 the day of application the dog vomited, then the dog developed diarrhea. The dog was treated symptomatically for gastroenteritis with trimethoprim sulfa and kaopectate. The symptoms in the dog progressed and the dog became jaundiced, lethargic, anemic, had a leukocytosis, low platelets, and blood chemistry abnormalities. The dog also developed ascites and a panhypoproteinemia. The dog was euthanized on May 21, 2018.

To be determined by Registrant

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


19. Provide supplemental information here

O - Unclassifiable/unassessable Reported diarrhoea and vomiting are an unspecific signs and may be associated with the later diagnosed jaundice. Lethargy is likely a consequence of reported digestive disorders. Reported jaundice, anemia, leukocytosis, low platelets, abnormal blood parameters, ascites and panhypoproteinemia are not expected after product application as inconsistent with pharmaco-toxicological product profile. Other causes have to be considered. Need for euthanasia is not expected after product application. Owner may have decided to euthanize the dog considering poor condition. Time to onset is short, though. Overall, a product connection is deemed to be unassessable.