Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-5254

2. Registrant Information.

Registrant Reference Number: 2018EB135

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.

13-JUN-18

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

24-APR-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)

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PMRA Registration No. 29780      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII 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.

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).

The patient is a 3 year old, 15.2 kg golden doodle. This patient received K9 Advantix II in 2016 with no previous reactions. On April 23, the pet owner applied 1 vial of k9 Advantix II large dog. On May 21st, the pet owner applied another vial of K9 Advantix II large 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

golden doodle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

15.2

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• Skin
  • Symptom - Itchy skin

• Nervous and Muscular Systems
  • Symptom - Aggressive behaviour

• Skin
  • Symptom - Lesion
  • Specify - wound

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 patient is a 3 year old, 15.2 kg golden doodle. This patient received K9 Advantix II in 2016 with no previous reactions. On April 23, the pet owner applied 1 vial of k9 Advantix II large dog. The patient became very itchy less than 24 hours after the application. The patient was not treated. On May 21st, the pet owner applied another vial of K9 Advantix II large dog. The patient became very itchy and tries to bite when he is handled. The patient developed wounds on the side of the dog. The patient was clipped and disinfected at the site of the wounds and treated with Isaderm cream. The outcome is unknown.

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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

B - Possible Itching is not expected to be generalised but rather be linked to the application site. However, may be a consequence of the uncomfortable feeling caused by the applied product. Biting and wound are not expected after product application either. However, in this case, wound may be a consequence of reported pruritus. Considering consistent time to onset for reported signs after each application, a product connection is deemed to be possible.