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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0356

2. Registrant Information.

Registrant Reference Number: 2014CK036

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.

16-JAN-14

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

22-FEB-09

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. Unknown

Product Name: K9 Advantix (unspecified)

  • 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.

Unknown

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 approximately 01-Feb-2009, a 14 year old, 18 pound, neutered, male, Welsh Corgi mix canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix (unspecified) (Imidacloprid - Permethrin) once topically by the owner. The product was continued monthly thereafter.

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

Welsh Corgi mixed breed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

18

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 - Death
    • Symptom - Neoplasia

12. How long did the symptoms last?

Unknown / Inconnu

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 22-Feb-2009, the dog had tumors around the neck, in the axillary region, and at the application site (application stie lump).On approximately 01-Feb-2013, the owner applied another dose of the product.On approximately 22-Feb-2013, the dog was on the way to the clinic to be euthanized when he died. It is unknown whether or not a 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

Tumors around the neck, in the axillary region, and at the application site are not anticipated with topical product exposure. Product has wide margin of safety. Time to onset long. Described signs may have various other causes in an old dog (e.g. papilloma). In the second course 4 years later the dog died 3 weeks after product exposure, however was going to be euthanized anyway. This indicates that other serious underlying medical conditions were present for the decision to euthanize the dog. Although final cause of death remained unclear, considering the observed signs that are not in line with products pharmacological profile, chronology and the age of the dog, product involvement was considered rather unlikely.