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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4083

2. Registrant Information.

Registrant Reference Number: 2018EB061

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.

10-MAY-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

07-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)

PMRA Registration No. 29777      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII small dog

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN
    • PYRIPROXYFEN

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).

On 07-May-2018, a x year old, man, in unknown condition, with a concomitant medical condition of a stent placed from a myocardial infarction that occurred in approximately 2008 and intermittent shortness of breath, was exposed to an unknown amount of Advantix (non - US Registered Product) (Imidacloprid - Permethrin) when he applied the product to his dog, washed his hands with an unspecified soap, then pet the dog and would bite his fingernails. Note: Product applied was Advantix Plus Spot-on 0.4ml (confirmed based on batch number).

To be determined by Registrant

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

Yes

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

  • Nervous and Muscular Systems
    • Symptom - Headache
    • Symptom - Ataxia
  • Respiratory System
    • Symptom - Difficulty Breathing
  • General
    • Symptom - Swelling

4. How long did the symptoms last?

Unknown / Inconnu

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

Yes

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)

Contact with treated area

What was the activity? pet the dog and would bite his fingernails.

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.

Oral

11. What was the length of exposure?

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

12. Time between exposure and onset of symptoms.

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

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.)

washed his hands with an unspecified soap, then pet the dog and would bite his fingernails. Approximately 4 hours post exposure, the individual experienced a severe headache and could not keep his balance. He was examined by an emergency room physician, administered diphenhydramine intravenously by the physician and started on an unspecified anti-nausea medication. On 08-May-2018, the individual experienced an increased in shortness of breath while walking his dog. On 09-May-2018, the individual experienced swelling in both legs, so he was examined again by an emergency room physician. A cardiac ultrasound, electrocardiogram and thoracic radiographs were performed, no abnormalities present. He was sent home with compression socks. On 10-May-2018, the swelling was improved. Note: Product applied was Advantix Plus Spot-on 0.4ml (confirmed based on batch number).

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

N - Unlikely Accidental indirect exposure. Contact with treated animal. Would not expect headache and ataxia after dermal exposure. No other reaction after product exposure reported, though irritation and/or numbness would be the first symptoms in case of dermal exposure or exposure to mouth. Later reported shortness of breath is not expected either. Sign likely associated with patient's medical history of heart disease and intermittent shortness of breath. Swelling in both legs is not expected and reported long time (2 days) after exposure. Other causes are more probable, e.g. warm weather, varices. Considering overall aspects, a product connection is deemed to be unlikely. Initial assessment changed by medical doctor. Assessment comment changed accordingly.