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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-3734

2. Registrant Information.

Registrant Reference Number: ProPharma Group case #: 2023SCPC00070366

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.

10-JUL-23

5. Location of incident.

Country: CANADA

Prov / State: SASKATCHEWAN

6. Date incident was first observed.

05-JUL-23

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. 33207 PMRA Submission No. EPA Registration No. Unknown

Product Name: MIRAVIS PRIME FUNGICIDE

Active Ingredient(s)
- FLUDIOXONIL
- PYDIFLUMETOFEN

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: Agricultural-Outdoor/Agricole-extérieur

Préciser le type: Wheat

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

The reporter did not clarify how they identified the product as Miravis Prime fungicide, and also notes that the patient was probably exposed to other pesticides/fungicides spread by plane in their area.

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: >12 <=19 yrs / >12 <=19 ans

3. List all symptoms, using the selections below.

System

Renal System
- Symptom - Other
- Specify - Kidney problems

Liver
- Symptom - Enlargement of the liver

Blood
- Symptom - Leukopenia

General
- Symptom - Fever

Eye
- Symptom - Bloodshot eye

Respiratory System
- Symptom - Respiratory congestion
- Specify - Spitting up phlegm

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

Unknown

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

Drift from the application site

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

11. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

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.)

2023SCPC00070366- The reporter, a family member of the patient, indicates an exposure to a pesticide containing the active ingredients fludioxonil and pydiflumetofen. Approximately five days before the day of initial contact with the registrant, the reporter indicated the patient inhaled pesticide drift from an aerial application to a neighboring field. Two days before the day of initial contact the patient was hospitalized and had developed kidney problems, an enlarged liver, low white blood cell count, fever, bloodshot eyes, and was spitting up phlegm. The reporter was advised that the symptoms were not consistent with exposure to this pesticide and the patient should continue to receive symptomatic and supportive medical attention. No additional information is available.

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Incident Report

Subform I: General Information

1. Report Type.

2. Registrant Information.

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

4. Date registrant was first informed of the incident.

5. Location of incident.

6. Date incident was first observed.

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.

7. b) Type of formulation.

Application Information

8. Product was applied?

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?

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

1. Source of Report.

2. Demographic information of data subject

3. List all symptoms, using the selections below.

4. How long did the symptoms last?

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

6. a) Was the person hospitalized?

6. b) For how long?

7. Exposure scenario

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

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

10. Route(s) of exposure.

11. What was the length of exposure?

12. Time between exposure and onset of symptoms.

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.)

To be determined by Registrant

14. Severity classification.

15. Provide supplemental information here.