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: 2019-1606

2. Registrant Information.

Registrant Reference Number: 27686

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.

21-JAN-19

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

18-DEC-18

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.

Active(s)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: k9 advantix II unknown size

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN
    • PYRIPROXYFEN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 18-Dec-2018, a 21 week old, 11.6 kg, male of unknown condition with was administered an unknown dose of K 9 ADVANTIX II (unknown product size), by Animal owner. It is unknown whether the product was used according to label.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

miniature american shepherd

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.4

7. Weight (provide a range if necessary )

11.6

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
  • Skin
    • Symptom - Itchy skin
  • General
    • Symptom - Abnormal behaviour
    • Specify - fly biting

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

24

Hour(s) / Heure(s)

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

later the same day, the dog was itchy at the application site but was recovered the next day. The dog presented to an emergency clinic on december 22nd with fly biting, partial seizures that progressed to tonic-clonic seizures. The dog was hospitalized and treated with keppra, phenobarbital, diazepam, propofol. Differential diagnoses included toxin, infectious, trauma, congenital, degenerative, epilepsy. Advanced imaging was declined and the dog was euthanized on december 23rd. A necropsy was performed on january 3rd 2019 with no significant findings. The attending DVM did not consider K9 Advantix to be the cause of the clinical signs.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here