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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2008-1755

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16123341

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

Address: 410 Swing Road

City: Greensboro

Prov / State: North Carolina

Country: USA

Postal Code: 27419

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

Human

4. Date registrant was first informed of the incident.

09-MAY-08

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

09-MAY-08

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. 100-1253

Product Name: Force CS Insecticide

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

7. b) Type of formulation.

Liquid

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.

Other

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 - Difficulty Breathing
    • Specify - Gasping for air
  • General
    • Symptom - Death
  • Cardiovascular System
    • Symptom - Other
    • Specify - cardiac incident

4. How long did the symptoms last?

Persisted until death

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)

Application

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.)

1-16123341: The reporter, a (work title), called on 5/9/08 to report a (age) year old male (work title) had passed away 5 days after he sustained dermal exposure to a product containing the active ingredient Tefluthrin. The patient had been exposed on 5/4/08. While he had been opening the container, some of the product splashed on his arms and stomach (unknown if concentrate or not). He had taken a shower sometime later that day and had not complained of any symptoms to his family. The morning of 5/9/08, the patient had suddenly begun gasping for air and 911 had been called. The patient was nonresponsive when paramedics arrived. According to the reporter, the patient had had a complete physical 2 months previously and was in good health with no known medical conditions. The reporter also revealed the patient had been involved in a farm accident 1-2 weeks prior to the call, in which he had been knocked down while removing a track off a tractor that had steel belts to it. Per the reporter, when he had viewed the deceased on 5/9 he had not seen any irritation or redness on the patient's areas of exposure. During the 5/9 call, the reporter requested and was given information about the safety profile of the product, including the fact that dermal exposure would not be expected to result in any systemic toxicity or death. Information was also given about symptoms which would have developed with inhalation or ingestion of the product. An autopsy was pending. Several follow-up calls have been placed regarding the necropsy results, but a return call has yet to be received.

To be determined by Registrant

14. Severity classification.

Death

15. Provide supplemental information here.

Exposure to this product would not be expected to result in any systemic toxicity or death. Skin exposure may cause irritation. Symptoms typically develop soon after the exposure and resolve spontaneously within 24 hours - product unlikely to be absorbed through skin. Symptoms are not expected to present 5 days after exposure.