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: 2014-0677

2. Registrant Information.

Registrant Reference Number: 2013CK120

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 77 Belfield Rd

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

27-MAY-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

18-MAY-13

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 26-Apr-2013, a 4 year old, 36.00 pound, spayed, female, Shetland Sheep Dog (Sheltie) canine, in good condition, with no concurrent medical conditions, was administered 1 tube of K9 Advantix II Large Dog (Imidacloprid - Permethrin - Pyriproxyfen) once topically by the owner.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Shetland sheep dog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

36

lbs

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

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • General
    • Symptom - Parasitism

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

On 17-May-2013 a large tick was found on the dog and removed. On 18-May-2013 the dog exhibited a penny sized wound where the tick was attached. The owner treated the area with triple antibiotic ointment and lidocaine. No diagnostics or treatments were performed. The status of the dog is unknown.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

Advantix' repellent effect against ticks is not 100%, thus attachment of individual ticks is possible if infestation pressure is high. Thus does not indicate lack of efficacy. Skin lesion is linked to tick removal