Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-3337

2. Registrant Information.

Registrant Reference Number: 2018TH024

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.

Human

4. Date registrant was first informed of the incident.

07-MAY-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: K9advantixII pipette size unknown

• 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.

Unknown

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).

A x yr old M pet owner reported signs of headache, nausea and dizziness and flu like symptoms after at least 3 separate applications of K9 advantix II to his pet. He reports his son (x yrs old M reported as 484731) had similar signs.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Medical Professional

2. Demographic information of data subject

Sex: Male

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Flu-like symptoms

• Nervous and Muscular Systems
  • Symptom - Headache
  • Symptom - Dizziness

• Gastrointestinal System
  • Symptom - Nausea

4. How long did the symptoms last?

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

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

No

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

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

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

A x yr old M pet owner reported signs of headache, nausea and dizziness and flu like symptoms after at least 3 separate applications of K9 advantix II to his pet. He reports his son (x yrs old M reported as 484731) had similar signs. An adult female in the house did not have signs. The signs last for about 2 days. The signs do not appear if the owner avoids touching the dog / washed his hands after contact.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

O - Unclassifiable/unassessable Unclear if direct or indirect exposure to product occurred. Would not expect nausea after product exposure. No oral exposure reported. Irritation and/or numbness would be the first symptoms in case of exposure to mouth. Headache, dizziness and flu like symptoms are not anticipated after product exposure. Other causes should be considered, e.g. infectious disease (other person in household with similar signs). Considering unknown time to onset and unknown exposure scenario, despite positive re-challenge, a product connection is considered unassessable. Preliminary assessment. Pending the final assessment after evaluation by Medical Doctor. If assessment is changed, the final statement will be submitted.

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Male

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Nausea

• General
  • Symptom - Flu-like symptoms

• Nervous and Muscular Systems
  • Symptom - Dizziness
  • Symptom - Headache

4. How long did the symptoms last?

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

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

No

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

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

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

A x yr old M pet owner reported signs of headache, nausea and dizziness and flu like symptoms after at least 3 separate applications of K9 advantix II to his pet. He reports his son (x yrs old M reported as 484731) had similar signs. An adult female in the house did not have signs. The signs last for about 2 days. The signs do not appear if the owner avoids touching the dog / washed his hands after contact.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.