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: 2013-6261

2. Registrant Information.

Registrant Reference Number: 2013CK008

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.

21-OCT-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. Unknown

Product Name: Advantage (unknown size)

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9.1 %

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 an unknown date in 2010, a 10 year old, 100 pound, male, Mixed Breed canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of Advantage (unspecified) (Imidacloprid) once topically by the owner. The product continued to be administered once per month.

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

Cross Breed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

100

lbs

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
    • 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

An unknown amount of time later in 2010, the veterinarian dianosed several lipomas on the dog.On an unknown date in Jun2011 the dog was examined by the veterinarian for enlarged masses on the dog. The dog was diagnosed with lymphoma. On an unknown date at the end of Jul2011 the dog died. No necropsy was performed. The owner initially contacted Bayer Animal Health to seek advise on how to control an active flea infestation and not to report the illness and death of this pet. No further information is expected.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The information regarding the death of the dog was casually provided during an inquiry. The level of information is very low. Nevertheless lymphoma and death are inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety and no carcinogenic potential. Oral LD50 in rat 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Development of lymphoma thus has other causes. The cause of death of this geriatric dog was probably due to signs of lymphoma. Product was used on animal before without causing any signs. Finally, a product relation can be completely excluded.