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: 2021-3300

2. Registrant Information.

Registrant Reference Number: 36384

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.

23-JUN-21

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

05-MAR-21

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. 29778      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II medium dog

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %
    • PYRIPROXYFEN
      • Guarantee/concentration .44 %

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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).

From Oct-2020 to May-2021a 0.83 year old, 6.2 kg, male Crossbred (Dog) in good condition with no concomitant medical conditions was administered one ADVANTAGE MULTI 20 (6 X 1.0 ML), (-), by Animal owner monthly. The product was used according to label (Yes). The dog was also administered one tube K9 Advantix II medium dog by animal owner monthly. 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?

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

Male

6. Age (provide a range if necessary )

0.83

7. Weight (provide a range if necessary )

6.2

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>6 mos <=1 yr / > 6 mois < = 1 an

10. Time between exposure and onset of symptoms

>2 mos <=6 mos / > 2 mois < = 6 mois

11. List all symptoms

System

  • Liver
    • Symptom - Elevated liver enzymes
    • Symptom - Other
    • Specify - Elevated Bile acids

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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 5 Mar 2021 the dog had a moderately elevated ALT. On 10 Mar 2021 the dog had an elevated post bile acids test. On 12 Apr 2021 bloodwork revealed a mildly elevated ALT. On 31 May 2021 the dog had a moderately elevated ALT and a moderately elevated AST. The pet owner suspects the elevated liver enzymes and bile acids are due to administration of advantage multi and K9 Advantix II. The veterinarian does not believe the products are responsible for the abnormal bloodwork and instead believes the dog has microvascular dysplasia. The outcome is unknown. Please see related case 36383 (same patient).


To be determined by Registrant

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

Minor

19. Provide supplemental information here