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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-3474

2. Registrant Information.

Registrant Reference Number: Prosar 1-19545554

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.

16-AUG-09

5. Location of incident.

Country: UNITED STATES

Prov / State: WASHINGTON

6. Date incident was first observed.

14-AUG-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: Gramoxone (non-specific)

  • Active Ingredient(s)
    • PARAQUAT
      • Unknown

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.25

Other Units: cup/gallon of water

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).

The product was applied to an unknown area at a dilution of 0.25 cup product per gallon of water on 08/14/2009.

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.

Data Subject

2. Demographic information of data subject

Sex: Male

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

3. List all symptoms, using the selections below.

System

  • General
    • Symptom - Swelling
    • Specify - "Swollen lips"
    • Symptom - Joint pain
  • Gastrointestinal System
    • Symptom - Tongue swelling
    • Symptom - Mouth Irritation
    • Specify - "Oral and esophageal ulcerations"

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)

Application

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?

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.)

1-19545554: A reporter called on 08/16/2009 to report his exposure to an herbicide containing the active ingredient Paraquat. According to the reporter, the product had been diluted to 0.25 cup of product per gallon of water and was being sprayed on 08/14/2009. The reporter stated that he was sprayed in the mouth several times with the diluted product. That night, the reporter's lips were swollen. By 08/15/2009, the reporter's lips and tongue were very swollen and he had sore joints. The reporter also described a previous head injury and current use of Neurontin, Zoloft, and a blood pressure medication for headaches. The reporter was advised that the product can be a toxic and very irritating substance. A recommendation was made to get medical evaluation for the signs and to determine the extent of ingestion and any toxicity. The reporter provided the local hospital's information for follow up. A Material Safety Data Sheet for the product was faxed to the hospital along with information on Paraquat poisoning and test procedures. On follow up with the hospital on 08/17/2009, a nurse stated that the initial reporter had been admitted on 08/16/2009. The nurse confirmed the sores in the mouth and the swollen tongue. The reporter remained stable overnight and did not have any respiratory signs. The nurse was uncertain whether samples for Paraquat testing had been collected. On follow up on 08/18/2009, a nurse stated that the reporter had been transferred out of the ICU and was stable. His renal and pulmonary functions had remained normal, and his oral and esophageal ulcerations were being managed. She was also uncertain whether samples for Paraquat testing had been submitted. It was determined later on 08/18/2009 that Paraquat samples had not been collected and would not be due to the lapse in time from the initial exposure. On follow up on 08/20/2009, a nurse stated that the reporter was no longer a patient at the hospital. Several attempts at follow up with the reporter were unsuccessful. No further information was obtained.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

The product was diluted, and it is unclear how much was ingested based on reporter's description of events.