Health Canada
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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-8568

2. Registrant Information.

Registrant Reference Number: 2007Aug12 Canada

Registrant Name (Full Legal Name no abbreviations): Monsanto

Address: 800 North Lindbergh Blvd.

City: Saint Louis

Prov / State: Missouri

Country: United States of America

Postal Code: 63167

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

Human

4. Date registrant was first informed of the incident.

10-AUG-07

5. Location of incident.

Country: UNITED STATES

Prov / State: KENTUCKY

6. Date incident was first observed.

20-JUN-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. 71995-23

Product Name: Roundup Weed + Grass Killer1 Ready to Use EPA Reg. No.: 71995-23

  • Active Ingredient(s)
    • GLYPHOSATE (PRESENT AS ISOPROPYLAMINE SALT OR ETHANOLAMINE SALT)
      • Guarantee/concentration 1.92 %

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. - 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).

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: Female

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Renal System
    • Symptom - Renal failure

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)

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.

>24 hrs <=3 days / >24 h <=3 jours

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.)

A Laboratory technician contacted the PCC about a (age) female that is in renal failure in the ICU. The physician wanted information about Roundup. The woman sprayed the Roundup RTU product on 6/20. She presented the next day to the HCF in renal failure. The lab tech does not know the actual name of the product, but believes she was just spraying for weeds. The actual laboratory values for the woman are not available. PCC discussed the product toxicity and advised the symptoms are unrelated to use of the product with questionable dermal exposure. Information was faxed to the ICU. On follow up, with the ICU nurse. The nurse is concerned about the back spray of the product the woman may have been exposed to. She has a history of diabetes and only one kidney. She has used Roundup RTU frequently. PCC advised the nurse of the product toxicity and that the symptoms are unrelated.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Poison Control Center advised the nurse of the product toxicity and that the symptoms are unrelated.