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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-4202

2. Registrant Information.

Registrant Reference Number: 2016KP106

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: 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. 11556-143

Product Name: k9 advantix II large dog

  • Active Ingredient(s)
      • Guarantee/concentration 8.8 %
      • Guarantee/concentration 44 %
      • 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 21-Apr-2016, a 1 year old, 33 pound, neutered, female,Australian Cattle Dog canine, in good condition, with no known concomitant medical conditions, was administered 1tube of K9 Advantix II Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. The canine was also administered an unknown dose of milbemycinoxime/lufenuron as an oral heartworm preventative.

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


2. Type of animal affected

Dog / Chien

3. Breed

Australian Cattle Dog

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

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms


  • General
    • Symptom - Lethargy
    • Symptom - Death
  • Blood
    • Symptom - Thrombocytopenia
  • Respiratory System
    • Symptom - Dyspnea
  • Gastrointestinal System
    • Symptom - Anorexia

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

Approximately 3 hours post application, the dog was lethargic. The owner bathed the dog with a dawn dish soap. On 22 Apr 2016, the dog was inappetant. The canine was examined by the attending veterinarian. A complete blood count showed a severely low platelet count of 33 K/uL (thrombocytopenia). No treatments were performed. Approximately 8 hours after the veterinary visit, the canine had heavy breathing (dyspnea). On 23 Apr 2016, the signs continued and the canine was examined by the attending veterinarian. A complete blood count showed the platelet count had decreased further to 13 K/uL. The canine was hospitalized and treated with an unknown dose of vitamin K via an unknown route by the attending veterinarian. The canine died at the hospital. No necropsy was performed. No further information is expected. This case is closed.

To be determined by Registrant

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


19. Provide supplemental information here

Lethargy and inappetence are unspecific sign and likely due to underlying condition, revealed later on. Thrombocytopenia and reported dyspnoea are not expected after product application as they are inconsistent with pharmaco-toxicological product profile. Death is not expected either an dlikely consequence of underlying condition. Time to onset for death is over one day, therefore allergic/anaphylactic reaction can be ruled out. Other causes should be considered, e.g. poisoning with anti-vitamin K, as suspected by the vet. Even though no necropsy was performed and time to onset is consistent for initially reported signs, considering all other aspects (unexpected signs/death, strong suspicion of poisoning), a product connection is unassessable.