Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4434

2. Registrant Information.

Registrant Reference Number: 2018TH037

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.

24-MAY-18

5. Location of incident.

Country: CANADA

Prov / State: PRINCE EDWARD ISLAND

6. Date incident was first observed.

24-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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: K9 Advantix unknown

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN

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7. b) Type of formulation.

Application Information

8. Product was applied?

No

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

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

• Skin
  • Symptom - Erythema
  • Symptom - Hyperesthesia
  • Specify - Application site tingling
  • Symptom - Irritated skin

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)

Pesticide Spill

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?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

<=30 min / <=30 min

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.)

On 24-May-2018, a x year old, woman, in unknown condition, with no known concomitant medical conditions, was exposed to an unknown amount of Advantix (non - US Registered Product) (Imidacloprid - Permethrin) when the product got all over her hands after she opened the package. The tube was ruptured and had leaked inside the packaging. Immediately post exposure, the individual experienced an irritation on her hands at the exposure site, so she washed her hands several times with an unspecified soap. Approximately 15 minutes post exposure, the individual experienced erythema on her hands at the exposure site and a tingling sensation on her hands at the exposure site. The individual was not examined by a physician. Due to the product being Non-US, no further information is expected; this case is closed.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

A - Probable Accidental direct exposure. Affected area compatible with exposed area. Reported irritation and erythema are consistent with individual dermal sensitivity after exposure to wet product. Tingling sensation on hands likely reflects paresthesia induced by permethrin. Considering short time to onset and sign location, a product connection is deemed to be probable. Initial assessment/causality confirmed by Medical Doctor.