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: 2013-4526

2. Registrant Information.

Registrant Reference Number: 2013AM205

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

Product Name: Advantage II (unknown size)

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PYRIPROXYFEN
      • 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).

One vial of Advantage II 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

Welsh corgi cardigan

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

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
  • Nervous and Muscular Systems
    • Symptom - Difficulty walking
    • Specify - limping
  • General
    • Symptom - Neoplasia
    • Specify - neoplasm
  • Gastrointestinal System
    • Symptom - Loss of appetite
    • Specify - inappetence
    • Symptom - Weight loss

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 15-May-2012, a 9 year old, male, Welsh Corgi Cardigan canine of unknown weight, in good condition with a history of allergies to fleas and mosquitoes, was administered 1 tube of Advantage II (dog-unspecified) (Imidacloprid- Pyriproxyfen) once topically by the owner. On an unspecified date the canine was limping. He was examined by a veterinarian and treated with an unknown dose of oral tramadol and an unknown dose of oral carprofen. The owner was instructed to keep the canine confined. On an unspecified date the canine was inappetent and had weight loss of approximately 6 pounds. The canine was examined by a veterinary specialist and an ultrasound was performed. A diagnosis of metastatic neoplasm was made. Approximately 2 days later the canine died. 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

The level of information of this case is low (unknown presentation of the product unknown weight, unknown time of death). Nevertheless metastatic neoplasia resulting in inappetance, weight loss and death are inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. The cause of death of this dog was due to metastatic neoplasia according to case description. Unknown onset time. Chronology inconsistent. Product was used on animal before without causing any signs. Finally, a product relation can be completely excluded.