Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-6718

2. Registrant Information.

Registrant Reference Number: PROSAR Case 1-15257909

Registrant Name (Full Legal Name no abbreviations): Syngenta Crop Protection

Address: 410 Swing Road

City: Greensboro

Prov / State: North Carolina

Country: USA

Postal Code: 27419

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

Human

4. Date registrant was first informed of the incident.

28-AUG-07

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

25-AUG-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.

Product Name: Paraquat (non-specific)

• Active Ingredient(s)
  • PARAQUAT
    • Unknown

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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: Unknown / Inconnu

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: Male

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

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Death

• Renal System
  • Symptom - Anuria

• Respiratory System
  • Symptom - Tachypnea
  • Symptom - Shortness of breath

• Liver
  • Symptom - Elevated liver enzymes

• Skin
  • Symptom - Jaundice

• Renal System
  • Symptom - Blood in urine

• Nervous and Muscular Systems
  • Symptom - Confusion

• Respiratory System
  • Symptom - Abnormal lung sounds
  • Specify - coarse lung sounds

• Skin
  • Symptom - Rash

• Liver
  • Symptom - Bilirubinuria
  • Specify - bilirubin increase

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?

13

Day(s) / Jour(s)

7. Exposure scenario

Unknown

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

Application

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

Unknown

10. Route(s) of exposure.

Oral

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

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.)

08/28/07 0750 Patient transferred to this hospital from nearby smaller facility-many details of exposure not available. Appears Patient was spraying product (unknown paraquat product) over the weekend, or late last week. Per caller is suspected he ingested AI. No other details of exposure avail. Patient presenting to first hospital with symptoms (gross hematuria and SOB) no information of onset of these symptoms. symptoms worsening over past 24-36 hrs per caller. On transfer to this hospital noted to be jaundiced SOB, confusion, rapid breathing and renal failure. Labs: elevated Bili - 16 Normal 0 .3-1.2 AST 199 Normal 12-45 ALT 170 Normal 10-40 Alkaline Phosphatase 297 Normal 37- 107 MD seeking testing information only. No specifics now about case management. Assessment: Testing protocol faxed to caller. 08/29/07 1151 Patient is currently in the Intensive Care Unit. Spoke Nurse: Patient Status: Patient is currently on a ventilator, and is paralyzed/sedated. Vital signs are reported as stable at this time. Patient is receiving bed-side hemodialysis (3 hrs sessions) No respiratory findings noted. No further details available regarding ingestion/exposure. Patient was seen by MD today Unable to speak with MD. Faxed Paraquat poisoning guide. Offered conference call with on call (name). Case and CB number provided. Patient Labs (8-29-07): Na - 139 Potassium - 5.9 Chloride - 96 CO2 - 18 BUN - 171 SCr - 15.6 (note - SCr was 14.3 on 8-28-07) Ion Gap - 25 Glucose - 160 Total Protein - 6.9 Albumin - 2.7 Calcium - 7.4 Bilirubin - 12.9 AST - 137 Alk Phos - 227 Serum Phos - 11.7 ALT - 122 Magnesium - 3.1 Osmolality - 338 08/31/07 1409 Spoke RN on M-ICU. RFTs continue to go upward (BUN= 196 ; SCr= 12.9). He continues to be sedated and on ventilator. 09/02/07 0751 Speaking with RN The patient remains sedated and on the ventilator. Today's (09/02/2007) labs include Scr - 10.4mg/dL, BUN 197mg/dL. The patient will continue hemodialysis tomorrow. 09/04/07 1031am Spoke with RN regarding patient status. Notified RN that lab result (Paraquat level) is expected on 9/5/07. Patient is currently ventilated and paralyzed (on Nibex and Versed). Lung sounds - coarse and worsening. Patient is jaundice, and has a generalized body rash. Patient vital signs are stable. Hemodialysis is occuring every other day. Critical Labs: BUN - 157 SCr - 6.7 Total Bilirubin - 24.4 Phosphorus - 11.7 09/05/07 1028 Spoke with RN regarding patient status. Verified for RN that lab result (Paraquat level) is still expected later today (9/5/07). Patient remains ventilated and paralyzed. Lungs are clear today. Jaundice and body rash have worsened. Patient vital signs remain stable. Hemodialysis is occurring every other day - and is scheduled for today (9-5-07). No further determination has been made regarding the specific Paraquat product suspected in this exposure. Critical Labs: BUN - 210 SCr - 6.7 Total Bilirubin - 23.1 Calcium - 6.7 09/06/07 1104am Call to ICU, spoke with RN. She indicated that patient passed away this am. Indicated he suffered a cardiac arrest and multi-system organ failure. Reported paraquat level was reported as 0.062 mcg/ml drawn on 8/28/2007 @ 09:55. She stated Patients date of admission was 8/25/07 and that was most likely the ingestion date. The history of what happened is still unclear. Patient has a history of alcohol abuse and recently had an apparatus attached to his car that required him to blow into it prior to the car operating. They are uncertain if he was depressed about this. They do know that patient was using the product the day of admission and also drinking beer; they are also uncertain if there may have been an accidental ingestion.

To be determined by Registrant

14. Severity classification.

Death

15. Provide supplemental information here.

Many details of exposure not available. Not yet determined if ingestion was intentional.