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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-2035

2. Registrant Information.

Registrant Reference Number: PROSAR Case #: 1-29963296

Registrant Name (Full Legal Name no abbreviations): Syngenta Canada Inc.

Address: 140 Research Lane, Research Park

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G4Z3

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

Human

4. Date registrant was first informed of the incident.

01-MAY-12

5. Location of incident.

Country: UNITED STATES

Prov / State: MINNESOTA

6. Date incident was first observed.

29-APR-12

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. 100-1075

Product Name: Force 3G Insecticide

  • Active Ingredient(s)
    • TEFLUTHRIN
      • Guarantee/concentration 29.1 %

7. b) Type of formulation.

Liquid

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.

Medical Professional

2. Demographic information of data subject

Sex: Male

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Respiratory irritation
    • Symptom - Shortness of breath
  • General
    • Symptom - Malaise
  • Cardiovascular System
    • Symptom - Chest tightness
  • Nervous and Muscular Systems
    • Symptom - Numbness
  • General
    • Symptom - Fatigue
  • Nervous and Muscular Systems
    • Symptom - Muscle pain
  • Cardiovascular System
    • Symptom - Other
    • Specify - Myocardial Infarction
  • Nervous and Muscular Systems
    • Symptom - Aching
    • Specify - achy

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

Occupational

8. How did exposure occur? (Select all that apply)

Drift from the application site

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.

Respiratory

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>30 min <=2 hrs / >30 min <=2 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.)

1-29963296- The reporter, a physician, reports a patient had presented to her following exposure to a pesticide containing the active ingredient Tefluthrin. The reporter indicated the [age] year old male (Subform II, #1) worked in a facility where the product was handled. Two days prior to presentation application equipment was being cleaned while the patient was in the general vicinity. Within several hours the patient experienced pressure in his chest, his tongue and roof of mouth were numb, he had shortness of breath, and he had a burning sensational in his nasal passages. The symptoms had resolved within 1.5 hours but he had some lingering malaise described as feeling achy and tired since the occurrence. The patients wife (Subform II, #2) was in the area when the initial exposure took place and developed a transitory burning sensation in her nasal passages that quickly resolved. The caller was advised the ongoing nature and severity of the symptoms seen were inconsistent with the expectations of the active ingredient and the finished product. She was also provided product literature to help guide her evaluation. On follow up the caller indicated laboratory tests had revealed the patient had a myocardial infarction (heart attack). She stated he was not admitted as the event was mild and was for the most part resolved at the point she had seen him. The patient was now under the care of a cardiologist on an outpatient basis. The physician commented the patient had a history of coronary artery bypass, hypertension and high blood pressure. She provided her opinion that the initial symptoms of respiratory irritation may have been consistent with exposure to the product, but that latter symptoms were more consistent with the heart attack and unrelated to the pesticide exposure. No further information is available.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Medical Professional

2. Demographic information of data subject

Sex: Female

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Irritated nose

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

Occupational

8. How did exposure occur? (Select all that apply)

Drift from the application site

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.

Respiratory

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

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.)

1-29963296- The reporter, a physician, reports a patient had presented to her following exposure to a pesticide containing the active ingredient Tefluthrin. The reporter indicated the [age] year old male (Subform II, #1) worked in a facility where the product was handled. Two days prior to presentation application equipment was being cleaned while the patient was in the general vicinity. Within several hours the patient experienced pressure in his chest, his tongue and roof of mouth were numb, he had shortness of breath, and he had a burning sensational in his nasal passages. The symptoms had resolved within 1.5 hours but he had some lingering malaise described as feeling achy and tired since the occurrence. The patients wife (Subform II, #2) was in the area when the initial exposure took place and developed a transitory burning sensation in her nasal passages that quickly resolved. The caller was advised the ongoing nature and severity of the symptoms seen were inconsistent with the expectations of the active ingredient and the finished product. She was also provided product literature to help guide her evaluation. On follow up the caller indicated laboratory tests had revealed the patient had a myocardial infarction (heart attack). She stated he was not admitted as the event was mild and was for the most part resolved at the point she had seen him. The patient was now under the care of a cardiologist on an outpatient basis. The physician commented the patient had a history of coronary artery bypass, hypertension and high blood pressure. She provided her opinion that the initial symptoms of respiratory irritation may have been consistent with exposure to the product, but that latter symptoms were more consistent with the heart attack and unrelated to the pesticide exposure. No further information is available.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.