Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6321

2. Registrant Information.

Registrant Reference Number: 2013CK092

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.

21-OCT-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

05-SEP-13

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. 11556-145

Product Name: Tempo SC Ultra Pest Control Concentrate

• Active Ingredient(s)
  • CYFLUTHRIN
    • Guarantee/concentration 11.8 %

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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 approximately 01-Sep-2013, a (age) year old, male, human, in good condition, with a known medical history of arthritis, was exposed to an unknown amount of Tempo SC Ultra Pest Control Concentrate (Beta-Cyfluthrin) when the product dripped on the patients hand. This patient also takes an unknown dose of an unknown medication an unknown number of time per day.

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: Male

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• Cardiovascular System
  • Symptom - Chest pain

• General
  • Symptom - Lethargy

• Respiratory System
  • Symptom - Shortness of breath

• Blood
  • Symptom - Anemia

• Cardiovascular System
  • Symptom - Other
  • Specify - myocardial infarction

4. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

Yes

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Unknown

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?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>3 days <=1 wk / >3 jours <=1 sem

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 approximately 05-Sep-2013 the patient developed chest pain, shortness of breath and lethargy. On 06-Sep-2013 the patient was examined by a physician and had an angiogram performed. The patient was diagnosed with Myocardial infarction and anemia. The patient was prescribed unknown medications. On 13-Sep-2013 the patient had further unknown test performed and medication doses were adjusted. As of 17-Sep-2013 the patient was recovered. additional information: followup with a family member showed an adverse reaction to a specific medication taken by the patient; the patient is reportedly doing well after adjustment of this medication. No further information is expected.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Direct accidental dermal product exposure. No respiratory exposure to the product reported. However the severe signs exhibited by this patient, the time to onset and the duration are inconsistent with the pharmacological and toxicological product profile even after dermal exposure. In fact, followup with a family member showed an adverse reaction to a specific medication taken by the patient. Thus overall a product relation is deemed to be unlikely. Initial assessment confirmed by medical doctor. No follow-up reporting