Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-5741

2. Registrant Information.

Registrant Reference Number: 2008Dec01 Cardinal Glennon 31488092

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.

Human

4. Date registrant was first informed of the incident.

05-DEC-08

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

21-NOV-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 71995-29

Product Name: Roundup Weed and Grass Killer Concentrate Plus

• Active Ingredient(s)
  • DIQUAT
    • Guarantee/concentration .73 %
  • GLYPHOSATE (PRESENT AS ISOPROPYLAMINE SALT OR ETHANOLAMINE SALT)
    • Guarantee/concentration 18 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

No

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?

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: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Rapid breathing
  • Specify - Rate increased

• Cardiovascular System
  • Symptom - Abnormally low blood pressure

• Nervous and Muscular Systems
  • Symptom - Seizure

• General
  • Symptom - Death

• Eye
  • Symptom - Pupil dilation
  • Specify - Myadrisis

• Blood
  • Symptom - Acidosis

4. How long did the symptoms last?

Persisted until death

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

1

Day(s) / Jour(s)

7. Exposure scenario

Non-occupational

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

Poisoning from ingestion of the pesticide

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

10. Route(s) of exposure.

Oral

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

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

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.)

The caller states that he runs a home for developmentally delayed adults and a (age) year old male resident who has pica recently ingested 16 ounces of Roundup Weed and Grass Killer Concentrate Plus. At twenty minutes post ingestion the caller states that the man looks good with no visible symptoms noted. MRPC discussed the product toxicity and advised of risks of symptoms. The caller was advised to take the man to the nearest emergency department for evaluation. The MRPC was unable to locate the HCF the patient was taken to for evaluation. On follow up approximately thirty minutes later the man was confirmed to be taken to the ED. He was is in a room at the ED, He appeared fo be comfortable with no symptoms noted. The MRPC spoke with the HCF staff and they had contacted the (State) PCC as well. They plan to give 50-100 grams of activated charcoal.. PCC did speak to him about gastric aspiration however he does not think this is feasible with this mentally challenged adult. Recommended to monitor chest x-ray and blood gases as necessary. IV access was in place and pulse oximetry. Further recommendation were made to monitor electrolytes, renal and hepatic function and acid-base balance. Treatment guidelines were faxed to the HCF. On follow up that evening in the ED, the man was resting. His vital signs were stable and no diarrhea was present. He did take the activated charcoal, but no IV access was obtained. The laboratory work was drawn and sent for testing. Initial chemistry was "good". The alkaline phosphatase 158, WBC 11.5, HCT 39.3. The ED was observing the man and planning on discharge. At approximately 5.5 hours post ingestion the man's respiratory rate increased and his blood pressure dropped. The caregiver stated he may have had a seizure. An IV line was inserted and one liter of fluids given. The man does have a history of seizures and his caregiver stated his symptoms seemed like his routine post ictal state. The plan at the HCF was to continue to monitor the man before deciding disposition. He appeared to be responding to IVFs, his blood pressure was returning to normal and no respiratory distress was noted. It was stated by the ED staff that no one in the ED witnessed the seizure. At approximately 8 hours post exposure the ED reported the man's valproic acid level was low. A CT scan of the head was ordered. The man has a pre-existing cold and is mouth breathing; his oxygen saturation is not good. The man was not at his baseline awareness as when he first arrived in the ED. The MRPC spoke with the ED physician, who reported the man has some mydriasis. The valproic acid level was confirmed to be 45 mcg/ml (50 is low therapeutic). The physician stated the man has a history of 'head banging' and that is why the CT scan was ordered. Arterial blood gases were pending. He stated there is no way to verify the amount of the product ingested and even if the man in fact ingested the Roundup. At ten hours post exposure, he has decreased oxygen saturation and a metabolic acidosis. Blood gas results on room air: pH 7.2, PO2 50, oxygen saturation 82%. The chest x-ray and CT scan were negative. The physician believes the man may have aspirated. He was admitted to the ICU. Follow up the next morning; the nurse reports the man is a mentally challenged individual so his baseline level of consciousness is unknown. He is nonverbal and sleepy. He does open his eyes and is responsive to tactile stimuli. The mydriasis persists. He has not had any repeat evidence of seizure activity since admission. He is on a dopamine drip at 20mcg/ml. The last blood pressure was 84/40 mm Hg, heart rate 83, respiratory rate 30's-40's. The respirations are shallow with diminished aeration. On later follow up the ICU nurse reported that the man expired at (date) The body was picked up by the coroner as this will be a coroner's case.

To be determined by Registrant

14. Severity classification.

Death

15. Provide supplemental information here.

(name) Case ID: 31488092. No verification of the amount ingested is possible and some question seems to exist whether or not the man in fact ingested the product.