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: 2013-6228

2. Registrant Information.

Registrant Reference Number: 2013CK093

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.

29-OCT-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

28-APR-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. 25131      PMRA Submission No.       EPA Registration No.

Product Name: Advantage 100

  • Active Ingredient(s)
    • IMIDACLOPRID

7. b) Type of formulation.

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).

Owner applied Advantage on April 28th and monthly till September 28th.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Chocolate labrador

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

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

<=30 min / <=30 min

11. List all symptoms

System

  • Skin
    • Symptom - Erythema
    • Symptom - Pruritus
  • Nervous and Muscular Systems
    • Symptom - Restlessness
  • Skin
    • Symptom - Red skin
  • General
    • Symptom - Licking
    • Symptom - Biting
    • Specify - biting toes

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

Not recovered / Non rétabli

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

After each application, the dog almost immediately appeared uncomfortable (restless). Within a couple of hours, the dog became pruritic (frequent grooming) with the affected area appearing to spread from the application site across the body to the toes over the 3-4 days following application. Within a couple of days post application, the dogs skin appeared red (visible over the belly). Towards the end of the month, the dog appeared less itchy/red, however, symptoms were not completely resolved prior to the next application (still frequently grooming, especially licking/biting toes).


To be determined by Registrant

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

Minor

19. Provide supplemental information here

The owner reported that this dog has also been investigated for allergic skin disease due to pruritus that has been apparent in previous years. The dog has not received Advantage prior to April 28 2013. The dog currently receives no medication and does not have any additional medical problems (other than possible allergic skin disease)