Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4042

2. Registrant Information.

Registrant Reference Number: 2018CP083

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.

15-MAY-18

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

08-MAY-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).

on May 08 2018 , a 14.9 kg, 5 year old male neutered canine wheaten terrier , was applied one tube K9advantixII large dog once topically by the owner.

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

Irish Soft-coated Wheaten Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

14.9

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

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• General
  • Symptom - Vocalizing

• Skin
  • Symptom - Pruritus

• Gastrointestinal System
  • Symptom - Drooling

• Skin
  • Symptom - Other
  • Specify - Licking at application site
  • Symptom - Irritated skin

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

13. Was medical treatment provided? Provide details in question 17.

No

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

four hours after application, the dog had was vocalising, was rubbing,was hypersalivating, was licking at application site and had application site irritation; reaction lasted 2 days

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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 Reported licking and irritation at application site are not expected after topical product application. Rubbing is not expected to be generalized but rather be linked to the application site. Vocalization is an unspecific sign. However, reported licking and irritation at application site, rubbing and vocalization may be a consequence of the uncomfortable feeling caused by the applied product. Hypersalivation is expected after oral uptake but not after dermal application of the product. However, in this case, may be associated with reported licking at application site. Considering short time to onset, a product connection is deemed to be possible.