Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4947

2. Registrant Information.

Registrant Reference Number: 2018RB085

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. 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).

On June 3, 2018 the pet owner applied K9 Advantix II medium to their 7 year old, male neutered, 9.2 kg crossbred dog.

To be determined by Registrant

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


Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Medical Professional

2. Demographic information of data subject

Sex: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.


  • Skin
    • Symptom - Paresthesia
    • Symptom - Blister
    • Symptom - Rash

4. How long did the symptoms last?

Unknown / Inconnu

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


6. a) Was the person hospitalized?


6. b) For how long?

7. Exposure scenario


8. How did exposure occur? (Select all that apply)


9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)


10. Route(s) of exposure.


11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

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

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

The pet owner had some of the product on her hand and wiped her nose and experienced a stinging sensation on her upper lip and then developed a blister and rash. The rash has improved but has not resolved. No medical treatment was provided. The dog also experienced an adverse reaction (linked report).

To be determined by Registrant

14. Severity classification.


15. Provide supplemental information here.

B - Possible Accidental direct and indirect exposure. Affected area is not fully compatible with exposed area, however as patient wiped nose with exposed hand, transfer to upper lip may have occurred. Reported stinging sensation is consistent with paresthesia induced by permethrin. Although a rash may occur in individuals with dermal sensitivity (mainly following direct product exposure), blister development is not expected and other causes should be considered. Time to onset is consistent. In the end, a product relation is considered possible. Preliminary assessment. Pending the final assessment after evaluation by Medical Doctor. If assessment is changed, the final statement will be submitted.

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?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms


  • Skin
    • Symptom - Pruritus
    • Symptom - Pain
    • Specify - application site pain
    • Symptom - Erythema
    • Symptom - Irritated skin
    • Symptom - Dermatitis
    • Symptom - Other
    • Specify - application site thickening
    • Symptom - Other
    • Specify - raw skin
  • Nervous and Muscular Systems
    • Symptom - Anxiety

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

The dog immediately began scratching at the application site, was distressed, and was painful at the application site. The application site looked red, irritated, and raw. The pet owner applied polysporin and administered Benadryl. On June 6, 2018 the pet owner took the dog to the veterinarian who noted a moist exudative dermatitis at the application site and the skin at the application site was thickened. Cytology was performed and cocci with neutrophils were observed. The area was clipped and cleaned and the dog was prescribed cephalexin and prednisone and daily cleaning with chlorhexadine was recommended. 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

B - Possible Whereas skin reaction at application site, e.g. scratching and reddening may occur in sensitive animals, would not expect pain, irritation, raw, and further reported moist exudative dermatitis and thickening directly related to product. However, likely linked to scratching at application site which caused signs by self-trauma, which secondarily became infected with bacteria. Distress likely associated with other reported application site skin disorders. Considering consistent time to onset, a product connection is deemed to be possible.