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: 2018-5921

2. Registrant Information.

Registrant Reference Number: 2018EB177

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.

17-JUL-18

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

12-JUL-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: K9advantixII 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).

The patient is a male 2 year old 16.6kg golden doodle. On July 10th, the pet owner applied 1 vial of K9 Advantix II Large dog. . The patient had received K9 Advantix II in the past without previous reactions.

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 (golden doodle X )

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

16.6

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • Skin
    • Symptom - Pruritus
  • General
    • Symptom - Licking
  • Skin
    • Symptom - Lesion
    • Symptom - Hair loss

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 July 12th, the patient had intense pruritus and started licking the application site and created a wound and alopecia from licking. The pet owner treated with vitamin E. The patient was seen at the clinic on July 17th, and treated with viaderm and cephaseptin. 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

B - Possible Whereas skin reaction at application site, e.g. pruritus may occur in sensitive dog, would not expect licking and wound at application site directly related to product. However, in this case application site wound along with application site alopecia may be associated with reported application site licking. Considering consistent time to onset and application site involvement, a product connection is deemed to be possible.