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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3130

2. Registrant Information.

Registrant Reference Number: 110072938

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.

13-JUL-11

5. Location of incident.

Country: UNITED STATES

Prov / State: OKLAHOMA

6. Date incident was first observed.

08-JUN-11

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).

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

Havanese

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.2

7. Weight (provide a range if necessary )

2

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 - Diarrhea
    • Symptom - Vomiting
    • Symptom - Anorexia
  • General
    • Symptom - Death

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?

Unknown

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

Havanese Dog named [name] (Canine Domestic) Signalment 10.0 wk neutered male weighing 2.0 lb. Was in good health previously. Normal environment: indoors mostly. Agent Exposure Roundup Weed and Grass Killer Ready To Use Plus (observed agent id) Suspected exposure occurred on Jun 08, 2011 at 12:00 PM CDT¿6 hr (possible ). Exposure involved unknown amount orally. The exposure was accidental, and occurred at animal owner yard. [Note : Owner states that her husband had sprayed with this product on Wednesday and [name] had been out in the treated area that day. On Thursday, [name] began having some diarrhea and began vomiting. The owner states that [name] has not vomited since yesterday but has not been eating since Friday evening. She suspects that [name] licked up some of the product or ate a treated plant. (by [initials] on Jun 12, 2011 at 08:38 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 low risk that those signs will be life-threatening. [Note : This product contains glyphosate. We could see mild and self-limiting GI upset (nausea, vomiting) from the surfactants in the product, if it was ingested while it was still wet. We would not expect to see any clinical signs from the active ingredient. (by [initial] on Jun 15, 2011 at 03:54 PM)] Clinical Status Diarrhea {Digestive} Time Observed: Jun 09, 2011 at 08:00 AM CDT Status: Mild Status: Unknown - [Note : accidentally entered. (by [initial] on Jun 15, 2011 at 04:23 PM)] End: Jun 12, 2011 at 05:00 PM CDT Status: Death Vomiting {Digestive} Time Observed: Jun 09, 2011 at 08:00 AM CDT Status: Moderate End: Jun 12, 2011 at 05:00 PM CDT Status: Death Anorexia {General Disorders} Time Observed: Jun 10, 2011 at 06:00 PM CDT Status: Moderate End: Jun 12, 2011 at 05:00 PM CDT Status: Death Death {General Disorders} Permanent: Jun 12, 2011 at 05:00 PM CDT Status: Death Potential Cause Roundup Weed and Grass Killer Ready To Use Plus 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 Planned/Recommended Care Take Animal to Veterinarian Purpose: Other; Importance: Important Who: Owner ; Willingness: Willing Implemented Jun 12, 2011 10:00 AM Have Veterinarian Call for Information Purpose: Information; Importance: Important Who: Owner ; Willingness: Willing Refused, Reason: Unknown Call Back With Questions Purpose: Information; Importance: Important Who: Owner ; Willingness: Willing Refused, Reason: Unknown Unplanned Care Fluid Therapy Details: Performed Jun 12, 2011 10:00 AM , Effectiveness: Not Effective , use (Appropriate ) Outcome Died , EPA max illness designation: D-A [Note : Died 6/12 (by [initial] on Jun 15, 2011 at 04:23 PM)]


To be determined by Registrant

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

Death

19. Provide supplemental information here

List of Contacts Jun 12, 2011 at 08:38 AM CDT [name] (assistant) interacted with [name] (owner) for reason: obtain help. [Note : Advised per Dr. [name] that the Roundup can cause some GI upset if it is ingested when still wet. Signs are usually fairly mild though and would be expected to start within a couple hours of exposure. Based on what we are seeing from [name] it seems likely that this is not related to any exposure to the Roundup. Since he is so young and has not eaten since Friday evening we would want him to get to a DVM right away for evaluation and treatment. [name] could easily develop hypoglycemia and dehydration. The DVM can contact us for more information. Call back with any questions or concerns. (by [initial] on Jun 12, 2011 at 08:52 AM)] Jun 15, 2011 at 04:16 PM CDT [name] (assistant) for reason: monitor case-out. [Note : Called owner to update case. LMOM with case and follow up number asking owner to call back. (by [inital] on Jun 15, 2011 at 04:19 PM)] Jun 15, 2011 at 04:23 PM CDT [name] (assistant) interacted with [name] (owner) for reason: update case-in. [Note : O calling back with update. O took puppy to vet on 6/12 and was place on fluids. Puppy passed later that day. O refused further consultation with vet. (by [inital] on Jun 15, 2011 at 04:35 PM)]