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: 2019-6498

2. Registrant Information.

Registrant Reference Number: 31430

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.

28-OCT-19

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

20-OCT-19

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. 29780      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II large dog

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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 19-Oct-2019, a 3 year old, 16.8 kg, female spayed Labradoodle Australian shepherd mix in good condition with no concomitant medical conditions was administered one K 9 ADVANTIX II 6 X 2.5 ML LGE DOG, KP0D2HT KP0CWBP (-), by Animal owner. The product was used according to label. This is not the first time the patient was receiving the product, there is no previous history of reaction.

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Crossbred dog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

16.8

kg

8. Route(s) of exposure

Skin

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

System

  • General
    • Symptom - Abnormal behaviour
  • Nervous and Muscular Systems
    • Symptom - Convulsions
    • Symptom - Collapse
    • Symptom - Fainting
  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Biting

12. How long did the symptoms last?

<=30 min / <=30 min

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

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

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 20-Oct-2019 less than 24 hours after the application of the product the patient was demonstrating abnormal behaviour, the patient fell over and had convulsions with a loss of consciousness, the patient vomited once, the patient bit the owners. The episode lasted approximately 2 minutes. The patient was seen less than 1 hour later at an emergency veterinary clinic. The patient was normal on physical exam and was not treated. Bloodwork was done which revealed a mild increase in bilirubine. The outcome is unknown.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here