Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4934

2. Registrant Information.

Registrant Reference Number: 2018EB125

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-18

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

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. 29779      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII extra large 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.

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 patient is a 9 year old 26.9kg, male Labrador cross. This patient is on Apoquel year round and received 16 mg q 24 hours. This patient is usually well controlled at this dose. He has been on Apoquel since 2014. On May 15th 2018, the pet owner applied 1 vial of K9 Advantix II extra large dog. They patient became very itchy all over his body, but especially his flancs and his feet after the application (exact onset of symptoms is unknown).

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

Labrador X

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

26.9

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 - Itchy skin
  • Symptom - Lesion

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

This patient is on Apoquel year round and received 16 mg q 24 hours. This patient is usually well controlled at this dose. He has been on Apoquel since 2014. On May 15th 2018, the pet owner applied 1 vial of K9 Advantix II extra large dog. They patient became very itchy all over his body, but especially his flancs and his feet after the application (exact onset of symptoms is unknown). The patient has lesions between his toes and on his chin and is being treated with viaderm.

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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 Itching is not expected to be all over body and localised at flanks and feet but rather be linked to the application site. Other causes should be considered e.g. allergies. Further reported lesions between toes and on chin are not expected after topical application of the product. However sign may be a consequence of reported itching. Though time to onset is long for later reported signs (16 days and more), considering unknown time to onset for initial reported sign, a product connection is unassessable.