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: 2020-1867

2. Registrant Information.

Registrant Reference Number: 33617

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.

08-JUN-20

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

01-JUN-20

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.

Active(s)

PMRA Registration No. 29780      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II large dog

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN
    • PYRIPROXYFEN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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 31-May-2020, a 5 year old, kg, female Boxer (German Boxer) in good condition with no concomitant medical conditions was administered one K 9 ADVANTIX II 6 X 2.5 ML LGE DOG, KP0 EGWZ (Jan-), by Animal owner. The product was used according to label (Unknown).

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Boxer

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Hair loss
  • Nervous and Muscular Systems
    • Symptom - Head shaking
  • Ear
    • Symptom - Other
    • Specify - Black secretions in the ears
  • Skin
    • Symptom - Lesion
    • Symptom - Red skin
  • General
    • Symptom - Licking
  • Skin
    • Symptom - Discolouration

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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 pet owner noticed on 01-Jun-2020 that the dog had alopecia behind the ears, was shaking his head a lot and had black secretions in the ears. The patient was seen for exam on 02-Jun-2020. On physical exam the patient also had wounds from scratching around the ears, redness and alopecia as well as stains from licking around the forearms and redness and alopecia on the stomach and inguinal area. The veterinarian noted that these might be due to seasonal allergies or food allergies. The patient was treated with Vanectyl-P, Otomax and Chlorexidine scrub. The outcome is unknown.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here