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: 2013-4542

2. Registrant Information.

Registrant Reference Number: 2013AM221

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.

13-AUG-13

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. 11556-134

Product Name: K9 Advantix 100

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %

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).

One vial of K9 Advantix 100 was applied topically by the owner to one spot on the dorsal midline.

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

Golden Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Weight loss
  • Respiratory System
    • Symptom - Runny nose
    • Specify - nasal discharge
  • Gastrointestinal System
    • Symptom - Loss of appetite
    • Specify - inappetent
    • Symptom - Anorexia
  • Respiratory System
    • Symptom - Coughing

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

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 approximately 01-Dec-2009, a 7 year old, Unknown weight, female, Retriever (Golden) canine, in fair condition, with history of mammary gland neoplasia, was administered 1 tube of K9 Advantix 100 (Imidacloprid - Permethrin) once topically by the owner. On an unknown date in Dec 2009 the dog had nasal discharge, then started loosing weight, was inappetent, then anorexic, coughing. Then ultimately died. The owner did not seek medical treatment and no necropsy was performed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Reliability of data questionable due to long time between occurrence and reporting. Death is not expected after product application as inconsistent with pharmacotoxicological product profile. The other reported signs (nasal discharge, inappetence, weight loss, cough) are also not expected after topical administration of the product. Other etiologies are more probable. However, considering, very low level of information (medical history and exact time to onset unknown, no vet exam, necropsy not available) and the long time until reporting, a product connection remains unassessable.