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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-4282

2. Registrant Information.

Registrant Reference Number: Prosar 1-19644779

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.

26-AUG-09

5. Location of incident.

Country: UNITED STATES

Prov / State: LOUISIANA

6. Date incident was first observed.

Unknown

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 Demon (Cypermethrin-based insecticide)

  • Active Ingredient(s)
    • CYPERMETHRIN
      • Unknown

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 applied to a home on 08/16/2009.

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.

Medical Professional

2. Demographic information of data subject

Sex: Female

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

3. List all symptoms, using the selections below.

System

  • General
    • Symptom - Swelling
    • Symptom - Edema
  • Respiratory System
    • Symptom - Pneumonia
    • Symptom - Coughing
    • Symptom - Coughing
    • Specify - "Coughing up thick green material"
    • Symptom - Abnormal lung sounds
    • Specify - "Diminished breath sounds"
    • Symptom - Respiratory congestion
    • Specify - "Coughing up thick green material"

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

Non-occupational

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

Contact with treated area

Amount of time between application and contact 8

Hour(s) / Heure(s)

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.

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.)

1-19644779: A reporter (physician) called on 08/26/2009 to report the exposure of a patient to an insecticide containing the active ingredient Cypermethrin. According to the reporter, the product was applied to the patient's home 10 days prior to the report (08/16/2009). The patient left the home at the time of product application and did not return home for 8 hours. At an unknown time following product application, the patient developed several episodes of facial swelling which required treatment at an emergency room. At the time of the report, the patient had angioedema and pneumonia and was being admitted to the hospital. The reporter was advised that the active ingredient is a pyrethroid which are typically diluted when applied. The product can be an irritant to the upper respiratory tract if inhaled and an irritant to the skin if dermal contact with wet product occurs. Once the product has dried, adverse signs are not expected. If the patient did contact wet product, hypersensitivity is possible but is a rare occurrence. Angioedema and pneumonia are not reported events with routine use of the product. The reporter was provided a Material Safety Data Sheet. On follow up on 08/28/2009, a nurse stated that the patient's pneumonia was persistent and that she was coughing up a thick green material. Her lung sounds were diminished but she did not require supplemental oxygen. The patient was receiving respiratory treatments every 6 hours and was afebrile. No further information was obtained.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

The signs described are not consistent with exposure to dried product residue. Exposure in this case is unknown. Re-entry interval is until dry. Patient did not return for 8 hours, therefore re-entry interval was exceeded and exposure unlikely.