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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6276

2. Registrant Information.

Registrant Reference Number: 2013CK024

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.


5. Location of incident.


Prov / State: UNKNOWN

6. Date incident was first observed.


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.


PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-127

Product Name: Advantage II Large Dog

  • Active Ingredient(s)
      • Guarantee/concentration 9.1 %
      • Guarantee/concentration .46 %

7. b) Type of formulation.


Application Information

8. Product was applied?


9. Application Rate.


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).

On an unknown date a 12.5 year old, spayed, female, Siberian Husky canine, in unknown condition, with no known concurrent medical conditions, was administered 1 tube of Advantage II Large Dog (Imidacloprid-Pyriproxyfen) once topically by the owner.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?


Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Siberian husky

4. Number of animals affected


5. Sex


6. Age (provide a range if necessary )


7. Weight (provide a range if necessary )


8. Route(s) of exposure


9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms


  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Bloating
    • Symptom - Loss of appetite
  • General
    • Symptom - Adipsia
  • Blood
    • Symptom - Hypoproteinemia
  • Renal System
    • Symptom - Other
    • Specify - cyst
  • Gastrointestinal System
    • Symptom - Other
    • Specify - fluid in abdomen
  • Liver
    • Symptom - Other
    • Specify - abnormality

12. How long did the symptoms last?

Unknown / Inconnu

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


14. a) Was the animal hospitalized?


14. b) How long was the animal hospitalized?

15. Outcome of the incident


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 an unknown date post administration the dog exhibited not eating, not drinking, lethargy, and bloat. The dog was seen by a veterinarian. Diagnostics were performed as follows: Blood work- low protein, ultrasound- liver abnormality and cyst on kidney. Fluid was removed from the dog's abdomen. Other treatments are unknown. The dog passed away at an unknown time post treatment. No necropsy was performed.

To be determined by Registrant

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


19. Provide supplemental information here

Described signs not expected, as inconsistent with product's pharmaco-toxicological profile. Signs reported more likely associated with the hepatic and renal disorder, which were diagnosed before the dog died. Also death is unlikely product-related as inconsistent with the pharmacotoxicological product profile. Unknown exposure date, unknown time to onset after product application, however, occurrence of fatal outcome probably not within close time of product application. 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. Cause of death probably due to underlying disease and old age according to case description. Therefore a product relation is considered unlikely.