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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6461

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0062398 (Report 605226)

Registrant Name (Full Legal Name no abbreviations): Bayer inc

Address: 2920 Matheson Blvd

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

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: OHIO

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. 29777      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII small dog

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

7. b) Type of formulation.

Other (specify)


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 04-Oct-2019, a 10 week old, approximately 9 pound, intact, male, Siberian Husky dog, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) via the topical route by the animal 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?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms


  • Gastrointestinal System
    • Symptom - Diarrhea
    • Symptom - Anorexia
    • Symptom - Vomiting
    • Specify - Emesis (multiple)
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Inappropriate defecation
  • Renal System
    • Symptom - Inappropriate urination
  • Nervous and Muscular Systems
    • Symptom - Collapse
  • General
    • Symptom - Death

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?


Day(s) / Jour(s)

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 05-Oct-2019, the dog exhibited diarrhea. On 07-Oct-2019, the dog was evaluated and administered unspecified vaccinations by the veterinarian and started on a bland diet. On 08-Oct-2019, the diarrhea worsened. The dog then exhibited anorexia and intermittent vomiting. The dog was evaluated by an emergency veterinarian. The parvovirus test ran was negative, and the dog was administered unspecified amounts of subcutaneous fluids, maropitant, and metronidazole by the veterinarian. The dog was not hospitalized. On 09-Oct-2019, the dog exhibited lethargy. The dog was examined by a veterinarian who performed blood work, radiographs, and a fecal exam; all were within normal limits. The dog was administered an unspecified dose of fenbendazole and maropitant by the veterinarian. On 10-Oct-2019, the dog exhibited inappropriate urination and inappropriate defecation. The dog was evaluated by another emergency veterinarian, hospitalized, and administered intravenous fluids. On 11-Oct-2019, the dog collapsed and died. 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

Reported diarrhoea is an unspecific sign and may have many potential causes. Time to onset is consistent, however duration is exceptionally long. Dog was vaccinated and diet was changed, after which dog's condition deteriorated. Vomiting, lethargy, anorexia and later reported inappropriate urination and inappropriate defecation are unspecific signs. Collapse and death are not expected in dogs, as it is inconsistent with the pharmaco-toxicological profile of the product. Other causes should be considered, e.g. other products used, or congenital disorders. No necropsy performed. Onset time is rather long for later reported signs. In the end, a product connection for the case is unassessable.