Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-5770

2. Registrant Information.

Registrant Reference Number: 2018RB122

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.

06-JUL-18

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

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)

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PMRA Registration No. 29778      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII medium dog

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

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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 July 2 or July 3, 2018 the pet owner applied K9 Advantix II medium to their 9.3 kg, female intact, 8 year old crossbred 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

Crossbred

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

9.3

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

• Skin
  • Symptom - Pruritus

• Nervous and Muscular Systems
  • Symptom - Shaking

• Skin
  • Symptom - Hyperesthesia

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?

Unknown

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

As the dog had a previous adverse event to product application, the pet owner applied vitamin E oil at the same time as applying the K9 Advantix II. An unknown time after application the dog began scratching, shaking, and skin twitching. The pet owner then applied vitamin E to the application sites, which had no effect.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here

Unclassifiable/unassessable - Even though more expected after oral uptake, permethrin has the potential to cause slight neurological disorders, e.g. twitching in particular susceptible dog. Scratching is not expected to be generalized but rather be linked to the application site. Other causes should be considered, e.g. allergies. Shaking is not expected either after topical product application and may have numerous other causes. Considering unknown time to onset, a product connection is unassessable.