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: 2016-2734

2. Registrant Information.

Registrant Reference Number: 2016KP052

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.

04-MAY-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

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. 11556-144

Product Name: K9 Advantix II extra large dog

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9.1 %
    • PERMETHRIN
      • Guarantee/concentration 44 %
    • PYRIPROXYFEN
      • Guarantee/concentration .46 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

4

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 an unspecified date in approximately Sep-2015, a 15 year old, male, Basenji canine, of unknown weight and condition,with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Extra Large Dog(Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner.

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Basenji

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

15

7. Weight (provide a range if necessary )

Unknown

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
    • Symptom - Other
    • Specify - Trauma

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

Died

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 an unspecified date post application, in Sep2015, the dog escaped from the yard, was hit by a car (trauma), and died. No necropsy was performed. No further information is expected; this case is closed. Note 1: previous applications were well tolerated. Note 2: The intent of the call was not to report this event but to inquire on the product with another dog.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Death is not expected in a dog after product application as it is inconsistent with the pharmaco-toxicological product profile. In this case, death is likely subsequent to trauma after being hit by a car. Low level of information (e.g., no necropsy was performed, time to onset is unknown and medical history are unavailable), as the intent of the call was not to report this event but to inquire about the product on a different dog. Considering all aspects and that the provided information about an alternative cause has been identified, a product connection is deemed to be unlikely.