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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-2464

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16206363

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

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.

29-MAY-08

5. Location of incident.

Country: UNITED STATES

Prov / State: RHODE ISLAND

6. Date incident was first observed.

15-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.

Product Name: Apron XL (non-specific)

  • Active Ingredient(s)
    • METALAXYL-M (MEFENOXAM)
      • Unknown

7. b) Type of formulation.

Other (specify)

Treated grass seed

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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

Site: Res. - Out Home / Rés - à l'ext.maison

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

The patient had spread the product onto his lawn about 2 weeks prior to the call. A spreader had been used to apply the product.

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 - Difficulty Breathing
    • Symptom - Other
    • Specify - Airway swelling
  • Cardiovascular System
    • Symptom - Hypotension

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?

Unknown

6. b) For how long?

7. Exposure scenario

Non-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.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

<=30 min / <=30 min

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.)

1-16206363: The reporter, a physician, called on 5/29/08 to report that a (age) year old male patient had had an anaphylactic reaction after using a product consisting of Mefenoxam treated seed. The patient had spread the product onto his lawn about 2 weeks prior to the call. A spreader had been used to apply the product. Within 15 minutes of using the product, the patient had developed difficulty breathing, airway swelling and hypotension. He had been treated in the ER with adrenaline IV, oxygen and steroids. The patient had made a full recovery. The unexpected nature of this reaction to the product was discussed during the 5/29 call. The physician was looking for data on the number of similar cases that had been reported. The request was forwarded on to the appropriate department.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.