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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2758

2. Registrant Information.

Registrant Reference Number: 2020RB004

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: 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. 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 May 2020 a 10 year old, 28kg, female neutered crossbred canine was administered K9 Advantix II extra large dog (lot KP0DXDA) by pet owner. The product was administered as per the 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Crossbred Dog

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

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms


  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Shaking
    • Symptom - Restlessness
  • Eye
    • Symptom - Blindness (temporary)
  • Nervous and Muscular Systems
    • Symptom - Dizziness
  • General
    • Symptom - Pacing
  • Nervous and Muscular Systems
    • Symptom - Abnormal gait
    • Symptom - Difficulty walking
    • Symptom - Head tilt
  • General
    • Symptom - Other
    • Specify - Decreased range of motion in the jaw
    • Symptom - Other
    • Specify - Dental disease
  • Nervous and Muscular Systems
    • Symptom - Muscle weakness
  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Disorientation
  • Eye
    • Symptom - Unreactive pupil
  • General
    • Symptom - Pain
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • Blood
    • Symptom - Other
    • Specify - Monocytosis
    • Symptom - Other
    • Specify - Basophilia
  • Skin
    • Symptom - Lesion

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 28 May 2020 the dog had decreased appetite and water intake. On 29 May 2020 the dog began shaking and was restless. On 30 May 2020 the dog presented to the veterinarian for blindness, diziness, pacing, walking in circles, and dragging her hind feet. Upon examination the veterinarian ideantified a left head tilt, circling to the left, bumping into things in the exam room, decreased range of motion in the jaw, dental disease, decreased range of moting in the right neck, knuckling on the left forefoot and both hind feet, hind limb weakness, and crossing over in the hind limbs. The dog was prescribed dexamethasone and Cerenia (maropitant citrate). On 4 June 2020 the dog was seen by a veterinarian for persistent symptoms and disorientation and lethargy. The veterinarian noted absent pupillary light response, pain on opening the mouth, ataxia, and neck stiffness. There was a mild monocytosis and basoplilia on bloodwork. The dog was prescribed Baytril (enrofloxacin), gabapentin, and Metacam (meloxicam). On 9 Jun 2020 the dog had steadily improved but had a sore on the face from bumping into an object. The dog was being given Polysporin by the animal owner. On 15 Jul 2020 the dog continued to improve but was not fully recovered. The outcome is unknown.

To be determined by Registrant

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


19. Provide supplemental information here