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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-1681

2. Registrant Information.

Registrant Reference Number: 2008May APSS 80039668

Registrant Name (Full Legal Name no abbreviations): Monsanto

Address: 800 N. 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.

Domestic Animal

4. Date registrant was first informed of the incident.

13-MAY-08

5. Location of incident.

Country: UNITED STATES

Prov / State: GEORGIA

6. Date incident was first observed.

17-APR-08

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. 71995-33

Product Name: Roundup Weed and Grass Killer Ready To Use Plus

  • Active Ingredient(s)
    • GLYPHOSATE (PRESENT AS ISOPROPYLAMINE SALT OR ETHANOLAMINE SALT)
      • Guarantee/concentration 2 %

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).

Unknown, other than owner applied the product.

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

Old English Bulldog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.25

7. Weight (provide a range if necessary )

15

lbs

8. Route(s) of exposure

Oral

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 - Diarrhea
    • Symptom - Anorexia
  • General
    • Symptom - Parvovirus infection
    • Specify - Parvovirus

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

Fully Recovered / Complètement rétabli

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

The owner suspects the dog may have been exposed to the product following application the day before. The next day, the dog started to have diarrhea and stopped eating or drinking. The owner stated that the dog had been diagnosed with parvovirus at the clinic. The owner elected to take the puppy home and treat at home. Owner gave SQ fluids at home. Dog finally started to eat and act like herself after about a week.


To be determined by Registrant

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

Major

19. Provide supplemental information here

APSS Case 80039668: Because the time course was poorly consistent, the amount was poorly consistent, and the findings were somewhat consistent, this substance was considered to have doubtful likelihood of causing the clinical situation.

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

Old English Bulldog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.25

7. Weight (provide a range if necessary )

15

lbs

8. Route(s) of exposure

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Diarrhea
  • General
    • Symptom - Death
    • Symptom - Parvovirus infection
    • Specify - Parvovirus

12. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 h

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

The owner suspects the dog may been exposed following application of product the previous day. The next day, the dog started to have diarrhea and stopped eating or drinking. The owner stated the dog was diagnosed with parvovirus at the clinic. The owner elected to take the puppy home and treat at home. Owner gave SQ fluids at home. Dog passed away.


To be determined by Registrant

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

Death

19. Provide supplemental information here

APSS Case 80039668: Because the time course was poorly consistent, the amount was poorly consistent, and the findings were somewhat consistent, this substance was considered to have doubtful likelihood of causing the clinical situation.