Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-1235

2. Registrant Information.

Registrant Reference Number: Prosar 1-17764931

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.

08-MAR-09

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

08-MAR-09

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.

Product Name: Non-specific Gramoxone

• Active Ingredient(s)
  • PARAQUAT
    • Unknown

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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.

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

• Respiratory System
  • Symptom - Pleural effusion
  • Specify - "Right lung infiltrate"

• Gastrointestinal System
  • Symptom - Other
  • Specify - "Oral swelling"

• General
  • Symptom - Bad breath
  • Specify - "Bad odor in the patient's mouth"

• Liver
  • Symptom - Elevated liver enzymes

• Blood
  • Symptom - Leukocytosis
  • Specify - "Elevated white blood cell count"

• Cardiovascular System
  • Symptom - Hypertension
  • Symptom - Tachycardia

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)

Poisoning from ingestion of the pesticide

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.

Oral

11. What was the length of exposure?

<=15 min / <=15 min

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.)

1-17764931: A reporter (Poison Control Center employee) called on 03/08/2009 to report the exposure of a female patient to a non-specific herbicide containing the active ingredient Paraquat. According to the reporter, the patient had taken one gulp from the mislabeled container and spit most of out. It was estimated that she may have ingested 1-2 teaspoons. At the time of the report, the patient was asymptomatic and was being decontaminated by paramedics prior to transport to the hospital. The reporter requested testing information. The reporter was provided testing information. On follow up on 03/09, the patient's nurse reported that the patient had been admitted to the intensive care unit (ICU) and was "very ill" with "impaired renal function." The nurse did not think any samples had been submitted for Paraquat testing. The nurse was unwilling to provide any further information out of concern for patient privacy. The nurse was advised that an on-call MD toxicologist was available for consult if needed. A document explaining Paraquat exposure diagnosis, first aid, and hospital treatment recommendations was provided to the caller via fax. On follow up later on 03/09, a nurse stated that the Paraquat test samples had not been submitted yet. The nurse was advised that the samples should be sent within 24 hours of exposure. A conference call was established between the treating physician and the MD toxicologist on 03/09. According to the physician, the patient had initially been treated with activated charcoal following product ingestion. The Paraquat test results were pending, and no renal complications had developed. A chest radiograph performed on 03/08 revealed a right lung infiltrate, but a recheck radiograph performed on 03/09 showed resolution of the infiltrate. The patient's respiratory status was unremarkable. The treating physician was advised that pulmonary, renal, and hepatic function should be monitored. The treating physician was also advised that tubular necrosis has been reported in some cases. A recommendation was made to check for proteinuria. The treating physician was advised that the patient was likely "out of the woods" if she has not experienced any pulmonary, renal, or hepatic complications by mid-day 03/10. On 03/11, the patient's Paraquat level was reported to be 0.038mcg/mL. On follow up on 03/11, the patient's nurse reported that the patient had had a nephrology consult and had been started on hemodialysis for three weeks. The patient's renal values had remained within normal limits, and the patient was producing normal amounts of urine. The patient had been intubated at some point and remained intubated at the time of this follow up. The patient did experience some oral swelling after product exposure and a bad odor was noticed coming from the patient's mouth. No lesions were noted. The nurse reported an increase in the patient's liver enzymes. The nurse inquired whether any personal protective equipment (PPE) was required when handling the patient or her bodily fluids. The nurse was advised that the patient's serum Paraquat level was 0.038mcg/mL at 22 hours post-ingestion. The nurse was then advised that reported symptomatic concentrations exceed 0.02ng/mL. A recommendation was made to wear PPE when handling bodily fluids although secondary toxicity is extremely unlikely. On 03/12, the lab called to report that a second Paraquat sample from the same patient was expected to arrive for testing. Another follow up was done on 03/12/2009. At this point, the patient's nurse reported that the patient was still intubated but was being weaned. Dialysis had been discontinued and lab work was being checked daily. A follow up call on 03/13 revealed that the patient had been extubated and was alert and oriented on room air. At the time of this follow up, the patient was receiving Bumex, a diuretic. On follow up on 03/16, the patient's nurse reported that the patient had been transferred out of ICU.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

(CONTINUED FROM SECTION 13): The patient's white blood cell count was slightly elevated; otherwise her lab work was within normal limits. At this point the patient was on Lisinopril for hypertension and tachycardia. It was unknown when the patient was expected to be released from the hospital.