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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2063

2. Registrant Information.

Registrant Reference Number: 33788

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.

18-JUN-20

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

16-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. 29777      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II small dog

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

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 16-Jun-2020, a 4.33 year old, 3.6 kg, male neutered Toy Poodle in good condition with no concomitant medical conditions was administered one K 9 ADVANTIX II 6 X 0.4 ML SM DOG, (-), by Animal owner. The product was used according to label (Yes).

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Toy Poodle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4.33

7. Weight (provide a range if necessary )

3.6

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Skin
    • Symptom - Itchy skin
    • Symptom - Inflammation of the skin

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

On 16-Jun-2020, an unknown time after application, the dog had application site itchiness. On 17-Jun-2020 the dog was seen by the veterinarian who said the dog had application site itchiness and application site inflammation. The dog was prescribed an antihistamine sheet, Vanectyl P, and was given an injection of Dexamethasone. Outcome is unknown. Please note that the dog had an applucation of Advantage Multi 10 on 15-Jun-2020 but did not have a reaction to that application site.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here