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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0012

2. Registrant Information.

Registrant Reference Number: 2017RB204

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.

01-NOV-17

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

Unknown

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. 29779      PMRA Submission No.       EPA Registration No.

Product Name: K9 advantix II Extra Large 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).

The pet owner applied K9 Advantix II extra large to their 21 month old, male neutered, 38.7 kg Golden Retriever on three separate occasions.

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

Golden Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.75

7. Weight (provide a range if necessary )

38.7

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Skin
    • Symptom - Red skin
    • Symptom - Irritated skin
    • Symptom - Dermatitis
    • Specify - Application site hot spot
    • Symptom - Itchy skin
    • Symptom - Pain

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 applied K9 Advantix II extra large to their 21 month old, male neutered, 38.7 kg Golden Retriever on three separate occasions. After each application they noted red irritated skin at the application site. On the third application the dog had a hotspot at the application site, was itchy at the application site, and had developed pain at the application site. The area was clipped and cleaned.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

B - Possible Whereas reddening, irritation and itching at application site may occur in sensitive animals, would not expect pain and hot spot development directly related to product. However, likely linked to scratching at application site which caused signs by self-trauma, which secondarily became infected with bacteria. Even though time to onset is unknown, considering application site involvement, a product connection is deemed to be possible.