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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3414

2. Registrant Information.

Registrant Reference Number: 2011TH018

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

Address: 77 Belfield Road

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.

17-MAY-11

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

13-MAY-11

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. 27661      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix 20

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN

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).

Owner applied to 2 dogs, a reaction was only noted in 1

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

Bichon

4. Number of animals affected

1

5. Sex

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Skin
    • Symptom - Paresthesia
    • Symptom - Lesion
    • Specify - dev a sore at appl site

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

Owner applied product on May 13, noticed dog was uncomfortable the next day. Pet was seen again at clinic and given steroid injection, which was ineffective. Owner was advised on May 17 to apply vitamin E. Owner advised care giver, whom dog was staying with the apply. Owner took dog to vet again May 20 as the dog had developed a sore at the application site. Awaiting update from vet.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Owner will also be reporting event