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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0752

2. Registrant Information.

Registrant Reference Number: 2015KP380

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.

15-JAN-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

02-DEC-15

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.       PMRA Submission No.       EPA Registration No. 11556-144

Product Name: k9 advantix II Extra large dog

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %
    • PYRIPROXYFEN
      • Guarantee/concentration .44 %

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

Product Name: Advantage II (cat unspecified)

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PYRIPROXYFEN

7. b) Type of formulation.

Liquid

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 approximately 02-Dec-2015, a (age) year old woman, in fair condition, with concomitant conditions of systemic scleroderma, mixed connective tissue disease, and back and neck disorders, was exposed to an unknown amount of K9Advantix II Extra Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) and Advantage II (cat - unspecified)(imidacloprid-pyriproxyfen) after applying them to her pets. The individual was also taking unknown doses ofhydroxychloroquine, lubiprostone, metoclopramide, cicamel,estradiol, venlafaxine hydrochloride, alprazolam, Vitamin B12,oxycodone, metaxalone, docusate, ondansetron, andcyclosporine since unknown dates in 2015.

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.

Other

2. Demographic information of data subject

Sex: Female

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

3. List all symptoms, using the selections below.

System

  • Nervous and Muscular Systems
    • Symptom - Confusion
    • Symptom - Ataxia
    • Symptom - Collapse
    • Symptom - Numbness
    • Symptom - Fainting

4. How long did the symptoms last?

Unknown / Inconnu

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)

Application

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.

Skin

11. What was the length of exposure?

Unknown / Inconnu

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.)

Approximately 8 hours post exposure, the individual felt confused, was ataxic, collapsed, fainted (syncope), and had numbness of her fingers. The individual was not evaluated by a physician.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Unclear whether direct or indirect exposure of the product is occurred. Reported neurological signs, collapse and fainting are not expected after exposure to the product. Numbness might be a consequence of fainting. Moreover concomitant medical condition of systemic scleroderma,mixed connective tissue disease, back and neck disorders and concomitant medication may have contributed to the reported signs. Despite, time to onset seems short,considering unexpected signs, overall a product connection is unlikely. Initial assessment/causality confirmed by medical doctor.