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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0021

2. Registrant Information.

Registrant Reference Number: 2017RB216

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: ONTARIO

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: K9 advantix II Small 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).

On November 6, 2017 the pet owner applied K9 Advantix II small dog to their 3 year old, 4 kg, Maltese/ Yorkshire terrier crossbred 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


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


  • Skin
    • Symptom - Rash

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

Fully Recovered / Complètement rétabli

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 November 6, 2017 the pet owner applied K9 Advantix II small dog to their 3 year old, 4 kg, Maltese/ Yorkshire terrier crossbred dog. An unknown time after application the dog developed a circular rash at the application site. The dog did not receive any treatment. The dog was bathed by the pet owner 9 days after application of the product with a flea/ tick shampoo as they saw fleas. On November 16, 2017 the veterinarian examined the dog and the rash had resolved.

To be determined by Registrant

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


19. Provide supplemental information here

N - Unlikely SLEE/Fleas. Would not expect rash development at application site directly related to product, however, likely dog scratched at site and caused sign by self-trauma. Pruritus was not reported. Other causes should be considered. The observation of fleas on treated animals is not surprising and does not represent the inefficacy of the product against fleas. Fleas must be on the animal to be killed as the product has no repellent activity for fleas. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated and number/frequency of previous applications was not reported. Therefore the flea cycle may have not been covered. Though application site is involved, however, considering all aspects, case is unlikely assessed.