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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-3715

2. Registrant Information.

Registrant Reference Number: 100081928

Registrant Name (Full Legal Name no abbreviations): Monsanto Canada Inc.

Address: 180 Kent Street, Suite 810

City: Ottawa

Prov / State: ON

Country: Canada

Postal Code: K1P 0B6

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

Domestic Animal

4. Date registrant was first informed of the incident.

16-JUL-10

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

20-JUN-10

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. 524-549

Product Name: Roundup Power Max Herbicide Cropshield Formula

  • Active Ingredient(s)
    • GLYPHOSATE (PRESENT AS POTASSIUM SALT)
      • Guarantee/concentration 48.7 %

7. b) Type of formulation.

Other (specify)

Concentration

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 III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

German Shepherd

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4.5

7. Weight (provide a range if necessary )

92

lbs

8. Route(s) of exposure

Oral

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Loss of appetite
  • General
    • Symptom - Hyperthermia
  • Respiratory System
    • Symptom - Cyanosis
  • Nervous and Muscular Systems
    • Symptom - Recumbent
  • Cardiovascular System
    • Symptom - Irregular heart rate
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Contact treat.area/Contact surf. traitée

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

Signalment 4.5 yr neutered male weighing 92.0 lb. Patient Note [Note : Piroxicam started 2 weeks ago for arthritis. (by FD on Jun 26, 2010 at 09:12 AM)] Agent Exposure Roundup Power Max Herbicide Cropshield Formula (observed agent id) Evidence exposure occurred on Jun 20, 2010 at 12:00 PM CDT (not specific ). Exposure involved 0.0 Not App (not specific) orally. The exposure was accidental, and occurred at animal owner yard. The agent was obtained from Other Retailer. The lot number was DNA. The expiration date was null. [Note : Product was sprayed 6/20/10 in the yard and near the dog's dishes outside. The dog started with vomiting 6/23/10. Yesterday evening, the vomiting was worse - increased frequency. The dog has been inappetant since yesterday am. On exam, laterally recumbent, hyperthermic - although his nail beds/pads were cold and cyanotic. MM - cyanotic. Low BP. Blood - thick and dark. Lab work is pending. DVM treated with NaCl IV fluids and Dexamethasone. The dog passed away 20 minutes ago. (by FD on Jun 26, 2010 at 09:12 AM)] Because the amount was somewhat consistent, the patient was considered to be at low risk of developing clinical signs. If signs develop, there is very low risk that those signs will be life-threatening. [Note : Roundup has a wide margin of safety. Can see mild vomiting and or diarrhea if a small amount of the product is ingested. Would not expect the clinical signs this pet demonstrated. (by JH on Jun 26, 2010 at 09:26 AM)] Temperature Measured: Jun 26, 2010 at 09:00 AM CDT Value: 105.3 deg F Status: High Potential Cause Roundup Power Max Herbicide Cropshield Formula Because the time course was poorly consistent, the amount was somewhat consistent, and the findings were poorly consistent, this substance was considered to have doubtful likelihood of causing the clinical situation. Patient Care Unplanned Care Take Animal to Veterinarian Details: Performed Jun 26, 2010 08:00 AM , Effectiveness: Not Applicable , use (Appropriate ) Fluid Therapy Details: Performed Jun 26, 2010 08:00 AM , Effectiveness: Not Applicable , use (Appropriate ) Chemistry Profile Details: Performed Jun 26, 2010 08:00 AM , Effectiveness: Not Applicable , use (Appropriate ) Complete Blood Count Details: Performed Jun 26, 2010 08:00 AM , Effectiveness: Not Applicable , use (Appropriate ) Monitor Electrolytes Details: Performed Jun 26, 2010 08:00 AM , Effectiveness: Not Applicable , use (Appropriate ) Blood Pressure Details: Performed Jun 26, 2010 08:00 AM , Effectiveness: Not Applicable , use (Appropriate ) Dexamethasone - Dog Details: Performed Jun 26, 2010 08:00 AM , Effectiveness: Not Applicable , use (Appropriate ) [Note : Discussed the case with the DVM. Discussed the safety profile of Roundup. Can see mild self limiting GI upset if some of the spray is ingested soon after spraying. The time frame and the signs the dog showed do not fit with a reaction to this product. (by JH on Jun 26, 2010 at 09:26 AM)]


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here