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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-4216

2. Registrant Information.

Registrant Reference Number: 2007May06 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.

21-MAY-07

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

19-APR-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. 7199529

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 %

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.

Medical Professional

2. Demographic information of data subject

Sex: Female

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

3. List all symptoms, using the selections below.

System

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Gagging
    • Symptom - Sore throat
    • Symptom - Other
    • Specify - swollen throat
    • Symptom - Stomach pain
    • Symptom - Difficulty swallowing
    • Symptom - Mouth Irritation
    • Specify - severe ulcerations of throat, esophagus and upper stomach with mild bleeding from ulcerations
  • Respiratory System
    • Symptom - Coughing up blood
    • Specify - coughing up bloody sputum with some pieces of skin

4. How long did the symptoms last?

<=30 min / <=30 min

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

5

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.

<=30 min / <=30 min

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 medic was calling from [State] about a (age) female who ingested approximately 3-4 oz of Roundup Weed and Grass Killer Concentrate Plus about 15 minutes ago with suicidal ideation. She has been dry heaving and prior to termination of call she began to vomit. The medic was calling for information on the product. The PCC discussed the product toxicity and advised to the emergency department for evaluation. The ED was notified and advised of the ingestion history. The PCC advised no activated charcoal since the woman is vomiting and questionable usefulness. Toxicity discussed and advised for risk for pulmonary and renal abnormalities. Recommended obtaining baseline labs including electrolytes, renal labs and observation for at least 48 hours and checking renal labs for any delayed renal involvement. On follow up, the woman was admitted to the HCF. Both the [State] PCC and MRPC were following the case. Admission follow up, the woman was alert with no further vomiting. Vital signs were blood pressure 127/65 mm Hg, blood pressure 105 bpm and respiratory rate 18 bpm. Her oxygen saturation was 96% on room air. The [State] PCC recommended they check and acetaminophen level as well. No lab work was back at the time of follow up. Due to both poison centers following the case the [State] PCC wanted to maintain follow up with their HCF. MRPC discussed the appropriate treatment for the product and recommended checking on results of renal labs and to follow renal studies. Follow up during the night, lab work acetaminophen < 10 mcg/ml, ETOH < 10, CMP, and CBC were ordered to be done in the morning. The nurse was unsure if an endoscope would be done tomorrow morning as well. The woman denies any stomach pain. A foley catheter was in place, and she was making urine. Follow up done at 10 AM EST, the womanżżżs vital signs were stable. She had complaints of throat feeling swollen and throat is sore. She is tolerating a regular diet and the HCF will continue to observe. There was no endoscope planned. The WBC was slightly elevated as the BUN and Creatinine, no specific values obtained by SPI who did the follow up. The woman remains on IVFs and antiemetics. PCC advised the womanżżżs status can be assessed by serum determinations of oxygenation status, renal and hepatic function, electrolytes, and acid base balance. Recommended continue to keep patient well hydrated, monitor RFT closely and vital signs for hypotension. Discussed that diquat causes renal tubule damage. The effects are generally transient and can be detected within 12 hours of ingestion. Acute renal failure may develop within 24 to 96 hours. Depending upon the diquat dose, renal damage may progress to acute oliguric renal failure, followed by return of normal kidney function by 10 to 14 days. (Per PI) PCC advised symptoms are really going to depend on dose ingested. Fluids and supportive care advised. Follow up, one day post exposure, temperature 103 F and decreased to 100.5 F after acetaminophen. Vital signs are blood pressure 108/63 mm Hg and heart rate 99 bpm. She complains of abdominal pain, but no further emesis. An endoscope was scheduled for 4/21/07. IVFS continue to infuse and renal labs results were unknown. On 4/21 on follow up the endoscope showed severe ulcerations of the throat, esophagus and upper stomach with mild bleeding from ulcerations. The woman was prescribed Carafate IV and clear fluids only. Renal function: Creatinine 3.4 mg/dL and Bun 26 mg/dL. The phosphorous level = 2.8 and the magnesium and WBC remain normal. Follow up on 4/22 all oral medications were switched to IV medication. The woman has difficulty swallowing, coughing up blood tinged sputum with some pieces of skin. IV Dilaudid was given for pain control. She tolerated Jell-O orally. Urine output remains good. A GI consult was ordered. Vital signs are heart rate 90 bpm, blood pressure 100/60 mm Hg, oxygen saturation 99% on room air.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Follow up on 4/23; four days post ingestion, the woman remains about the same at the time of follow up. Electrolytes normal except K = 2.7 mEq/L and 80 mEq KCl being given. Renal function BUN 23 mg/dL and Creatinine = 2.3 mg/dL. The CBC: Hgb 10.1 and Hct 29.7, no LFTs were drawn. She continues with good urine output. She continues with liquid carafate, lidocaine viscous and clear liquid diet. Plan to continue to monitor renal function and electrolytes until normal. Vital signs were stable. Follow up on 4/24, she is stable and the treatment remains unchanged. IVFs with KCl continue as K = 2.7 mEq/L. Magnesium = 1.6. Phosphorous = 1.6. renal function: BUN = 16 mg/dL, Creatinine = 1.8 mg/dL, No further mention of any vomiting difficulty with swallowing. PCC will continue to follow up. Over the next several days there was no new information to report and the patient was stable and was discharged from (name)