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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-1693

2. Registrant Information.

Registrant Reference Number: Prosar 1-18435908

Registrant Name (Full Legal Name no abbreviations): Syngenta Crop Protection 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.

12-MAY-09

5. Location of incident.

Country: UNITED STATES

Prov / State: CONNECTICUT

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)

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

Product Name: Paraquat (Non-specific)

  • Active Ingredient(s)
    • PARAQUAT
      • Unknown

7. b) Type of formulation.

Application Information

8. Product was applied?

Unknown

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

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Shortness of breath
    • Symptom - Other
    • Specify - Bilateral alveolar hemorrhage
  • Renal System
    • Symptom - Renal failure

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

Non-occupational

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

Other

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.

Unknown

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.)

1-18435908: The reporter, a physician, called on 5/12/09 regarding a (number) year old male patient who may have been exposed to Paraquat-contaminated marijuana. According to the reporter, the patient did not have any known, witnessed exposure to the Paraquat ¿ the patient smoked marijuana and the physician was just trying to rule out possible toxicity. The patient had been diagnosed in 2007 with interstitial lung disease, and had a two year history of shortness of breath. Three weeks prior to the call, the patient¿s symptoms had worsened and bilateral alveolar hemorrhage had developed. At some unspecified time, the patient had been hospitalized and was in the ICU in critical condition on a ventilator. During the 5/12 call, information on testing for Paraquat and treatment guidelines were faxed to the reporter. It was also discussed that studies have demonstrated that smoking marijuana treated with Paraquat is not a relevant exposure. Follow-up calls to the reporter on 5/14 and 5/17 revealed that the patient was on steroids, still in ICU on the ventilator with a slightly improved respiratory function, and that he had developed mild renal failure. The reporter had also spoken with the state toxicologist, who was of the opinion that the patient¿s lung problems were inconsistent with exposure to Paraquat. Blood had been drawn for Paraquat testing and serum levels were still pending. By 5/20, the patient¿s condition had improved, though he was still critical and on a ventilator. His supplemental oxygen level had been decreased from 100% to 60%. Note: This case is still in the process of being followed every several days; no further details are available at this time.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

No evidence that Paraquat was sprayed on the marijuana; nor is there any evidence of exposure to Paraquat. The question was asked by the treating physician even though the state toxicologist indicated that the patient's lung problems were inconsistent with exposure of Paraquat.