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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0229

2. Registrant Information.

Registrant Reference Number: ProPharma Group case #: 1-46465960

Registrant Name (Full Legal Name no abbreviations): Syngenta 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.

06-DEC-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

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. 27428      PMRA Submission No.       EPA Registration No.

Product Name: DEMAND CS INSECTICIDE

  • Active Ingredient(s)
    • LAMBDA-CYHALOTHRIN

7. b) Type of formulation.

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).

1-46465960 - A non-company product called Dragnet was applied at the same time. The active ingredient and application rate for this product is unknown.

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

  • Skin
    • Symptom - Erythema
    • Symptom - Rash
  • Respiratory System
    • Symptom - Respiratory irritation

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)

Contact with treated area

What was the activity? Returning to the residence after 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.

Respiratory

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.)

1-46465960 - The reporter indicates an exposure to a pesticide containing the active ingredient lambda-cyhalothrin. Starting approximately five months before the day of the initial contact with the registrant, the reporter had his apartment treated every two weeks with the product and non-company product for a bug bed infestation. After every application, the reporter developed respiratory irritation upon reentry to the apartment, and at an unknown date developed a red rash on his body. He currently is not living at the apartment due to the symptoms, and he sought medical care for his rash. His wife in on chemotherapy since an unknown date. The reporter was advised that the product can cause a temporary allergic reaction, and that his symptoms would not be expected with the brief exposure he described. The reporter was also advised to consider that his symptoms might be due to exposure to the chemotherapy drugs. No follow-up was done. No additional information is available.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Female

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

3. List all symptoms, using the selections below.

System

  • Gastrointestinal System
    • Symptom - Diarrhea
    • Symptom - Vomiting
  • Respiratory System
    • Symptom - Nose bleed
  • Skin
    • Symptom - Erythema
    • Symptom - Inflammation of the skin
  • Respiratory System
    • Symptom - Respiratory irritation
  • Nervous and Muscular Systems
    • Symptom - Difficulty walking
  • General
    • Symptom - Pain

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)

Contact with treated area

What was the activity? Returning to the residence after 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.

Respiratory

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.)

1-46465960 - The reporter indicates his wife had an exposure to a pesticide containing the active ingredient lambda-cyhalothrin. Starting approximately five months before the day of the initial contact with the registrant, the reporter had their apartment treated every two weeks with the product and non-company product for a bug bed infestation. After every application, the reporters wife developed respiratory irritation upon reentry to the apartment, and at an unknown date developed vomiting; diarrhea; nose bleeds; and swollen, red, painful legs and feet. She has difficulty walking due to the pain in her legs and feet. She currently is not living at the apartment due to the symptoms, and her doctors cannot determine the cause of her symptoms. She in on chemotherapy since an unknown date. The reporter was advised that the product can cause a temporary allergic reaction, and that the symptoms would not be expected with the brief exposure described. The reporter was also advised to consider that the symptoms might be due to exposure to the chemotherapy drugs. No follow-up was done. No additional information is available.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.