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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-5258

2. Registrant Information.

Registrant Reference Number: 2018EB139

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.

Country: CANADA

Prov / State: QUEBEC

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. 29778      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII medium dog

  • Active Ingredient(s)

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).

The patient is a 8 month old male neutered 10.4 kg English cocker spaniel. On approximately March 1st, the pet owner applied 1 vial of K9 Advantix II medium dog topically on the patient. On June 1st, the pet owner applied another vial of K9 Advantix II medium dog.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

English Cocker Spaniel

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms


  • Skin
    • Symptom - Itchy skin
  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Vomiting
  • General
    • Symptom - Fever

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

This was the first time the patient was receiving the product. Approximately 2 days later, the patient developed anorexia and was itchy. Bloodwork and x-rays were done, no abnormal findings. Patient was treated with Cerenia and famotidine. The patient recovered about 3 weeks later. On June 1st, the pet owner applied another vial of K9 Advantix II medium dog. Approximately 2 days later, the patient developed fever, vomiting and anorexia. The patient was seen by an emergency vet clinic and treated. The patient still had anorexia on June 13th. The outcome is unknown.

To be determined by Registrant

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


19. Provide supplemental information here

O - Unclassifiable/unassessable Reported itchy skin is not expected to be generalized but rather be linked to the application site. Anorexia is unspecific and may have numerous other causes. Reported vomiting after subsequent application of the product is rather unspecific in dogs and may have multiple potential causes. Oral uptake was not reported. Fever is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Time to onset is bit long (2 days). Other causes must be considered. Considering overall aspects, a connection with the product is unassessable.