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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-1068

2. Registrant Information.

Registrant Reference Number: 2018TH001

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.

31-JAN-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

23-JAN-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. 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 Jan 23 2018 a veterinarian applied 1 tube of K9 advantix Large dog to a 3 yr old 17.7 kg lab mix.

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Crossbred (Dog)

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

17.7

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

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Abnormal gait
  • Skin
    • Symptom - Hyperesthesia
    • Specify - Application site twitching
  • Gastrointestinal System
    • Symptom - Loss of appetite
    • Specify - Decreased appetite

12. How long did the symptoms last?

Unknown / Inconnu

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

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

2 hours later the owner reported an odd gaint in the hind and and application site skin spasm (twitch), the dog was also eating less than usual. The dog was bathed and treated with vitamin E.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

O - Unclassifiable/unassessable Reported odd gait in the hind limb is not expected after product application as inconsistent with pharmaco-toxicological profile of the product. Other causes should be considered. Application site twitching might reflect local dermal sensitivity to the product. Decreased appetite is an unspecific sign and may have numerous other causes. Though time to onset is short, considering overall aspects, a product connection is unassessable.