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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-1174

2. Registrant Information.

Registrant Reference Number: Prosar case 1-15809108

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.

21-FEB-08

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW JERSEY

6. Date incident was first observed.

12-SEP-07

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: Demand CS

  • Active Ingredient(s)
    • LAMBDA-CYHALOTHRIN
      • Guarantee/concentration 9.7 %

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

Product Name: Tempo SC Ultra

  • Active Ingredient(s)
    • CYFLUTHRIN

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Res. - In Home / Rés. - à l'int. maison

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

The product was sprayed in the reporter's condo/apartment on 9/12/2007 in conjunction with a second product, Tempo SC Ultra (product code 21648, manufactured by Bayer Healthcare). The second product contains the active ingredient Cyano (4-fluro-3-phenyoxyphenyl)methyl3-(2,2-dichlorethenyl)-2,2-dimethylcyclopropanecarboxylate) aka beta-cyfluthrin at 10-30% concentration. The products were being sprayed on a routine basis (monthly).

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: Female

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

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Burning throat
  • General
    • Symptom - Flu-like symptoms
  • Respiratory System
    • Symptom - Coughing
    • Symptom - Coughing up blood
    • Symptom - Pneumonia
  • Nervous and Muscular Systems
    • Symptom - Memory loss
    • Symptom - Difficulty concentrating
  • Respiratory System
    • Symptom - Shortness of breath

4. How long did the symptoms last?

>2 mos and <=6mos />2 mois et <=6mois

5. Was medical treatment provided? Provide details in question 13.

Yes

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Non-occupational

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

Contact with treated area

What was the activity? Reporter's condo/apartment was sprayed.

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>8 hrs <=24 hrs / > 8 h < = 24 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.)

# : The reporter called on 2/21/08 to report that she had been exposed to two pesticide products when her condo/apartment had been sprayed on 9/12/07. The spraying was done on a routine basis (monthly). The first product involved contains the active ingredient Lambda-Cyhalothrin while the second product contains the active ingredient beta-cyfluthrin or Cyano (4-fluro-3-phenyoxyphenyl)methyl3-(2,2-dichlorethenyl)-2,2-dimethylcyclopropanecarboxylate). The reporter stated she felt a burning sensation in her throat and flu-like symptoms after the products were sprayed. That same day she went to see a physician, who tested for strep throat and placed the reporter on antibiotics pending the throat cultures. The reporter never took the antibiotics. A few days later she began coughing and experienced some hemoptysis. The reporter went to an emergency medical facility, was diagnosed with bilateral pneumonia and was given antibiotics. When the caller phoned in the report on 2/21/08, she stated she was still experiencing memory loss, loss of focus, and mild shortness of breath. A follow-up call was placed on 2/27/08, which elicited a response from the reporter on 2/28/08 that she was still experiencing symptoms including shortness of breath all the time. The reporter was advised that she should continue to follow-up with her physician.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

It is unlikely that the symptoms are the result of the incident discussed above. The reporter was diagnosed with a suspected strep throat and antibiotics were prescribed but not taken. Subsequently the reporter was diagnosed with bilateral pneumonia and antibiotics was provided. This is further supported by information that the apartment was sprayed on a routine basis (monthly) and the symptoms occured coincidently with a serious respiratory infection which is not directly related to the products mentioned.