Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-5404

2. Registrant Information.

Registrant Reference Number: 2014CK346

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 77 Belfield Rd

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

20-OCT-14

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

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: Advantage (unknown)

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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

Site: Unknown / Inconnu

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

On an unspecified date in 2010, a (age) year old, man, in unknown condition, with no known concomitant medical conditions, was exposed to an unknown amount of Advantage (unspecified) (Imidacloprid) when he got some of the product on his hands, then touched his lips.

To be determined by Registrant

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

No

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: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Neoplasia

• Skin
  • Symptom - Tingling skin

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?

Yes

6. b) For how long?

Unknown

7. Exposure scenario

Unknown

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)

None

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

Unknown / Inconnu

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.)

Immediately after exposure, the patient had a tingling sensation, which resolved within about 2 minutes.On an unspecified date in 2012, the patient had an intestinal mass. An unspecified amount of time later, the mass was removed.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Direct product exposure occurred and time to onset consistent for initial tingling. Advantage contains benzyl alcohol which has mild irritant properties, hence a relation with tingling is possible. However other reported sign of intestinal mass is not expected with product exposure. Time to onset is long for this sign with approx. 2 years and sign is not in line with pharmaco-toxicological product profile. Considering the more serious sign of neoplasm, a product relation was considered unlikely for this case. Initial assessment confirmed by medical doctor.