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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-1067

2. Registrant Information.

Registrant Reference Number: 2018RB007

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-FEB-18

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

08-FEB-18

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 an unknown date in February 2018 the pet owner applied K9 Advantix II for large dogs to their 22 month old, 22.4 kg, male neutered, Australian Shepherd dog.

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

Australian Shepherd Dog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

22

7. Weight (provide a range if necessary )

22.4

kg

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

Unknown / Inconnu

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • General
    • Symptom - Hyperactivity
  • Skin
    • Symptom - Itchy 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

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

The dog developed ataxia, circling behavior, and was pruritic around the facial and hindquarters area. The dog was seen by a veterinarian and prescribed a systemic antibiotic and a topical steroid/ antimicrobial. The dog recovered an undetermined time later. The pet owner also reported to the veterinarian that when the K9 Advantix II was applied on June 30, 2017 the dog was itchy and vomited, then recovered an undetermined time later.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

O - Unclassifiable/unassessable Even though more expected after oral uptake, Permethrin has the potential to cause slight neurological disorders (e.g. ataxia) in particular susceptible dogs. However, time to onset is unknown in this case. Circling behavior is a very unspecific sign and may have other causes. Reported pruritis is not expected to be localized around the face and hindquarters but rather be linked to the application site. Other causes should be considered, e.g allergies. Overall, considering all aspects, a product connection is unassessable.