Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6131

2. Registrant Information.

Registrant Reference Number: 2018TH100

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.

01-AUG-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

27-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. 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 May 27 2018 a pet owner applied one tube of K9 advantix II med dog to a 23 month old 9.3 kg MN chihuahua cross.

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 (chihuahua X )

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.91

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

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Abnormal behaviour

• Respiratory System
  • Symptom - Panting

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Adipsia
  • Symptom - Lethargy

• Nervous and Muscular Systems
  • Symptom - Shaking

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

The dog was vomiting, sharking and panting that evening and the owner reported it was like he "was going to have a seizure". The dog improved after 48 hours but was still vomiting, not eating or drinking well, not wanting to move around/go outside. The dog was recovered after approx 7 days. The dog has a similar response after product use the previous month.

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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

B - Possible Reported vomiting is more expected after oral uptake than after dermal application of the product. However, an oral product uptake cannot be excluded. Sharking is an unspecific sign. However, it may be a consequence of the uncomfortable feeling caused by the applied product. Panting is not expected with appropriate topical product use. It may rather be a behavioural reaction to product sensation than a sign of respiratory illness. Later reported systemic disorders are unspecific signs. However, they may be associated with reported vomiting. Though time to onset is bit long (2 days) for later reported signs, considering consistent time to onset for initial signs, a product connection is deemed to be possible.