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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-2846

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16243665

Registrant Name (Full Legal Name no abbreviations): Syngenta Crop Protection Canada, Inc.

Address: 140 Research Lane, Research Park

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G4Z3

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

Domestic Animal

4. Date registrant was first informed of the incident.

06-JUN-08

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

06-JUN-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. 8661      PMRA Submission No.       EPA Registration No.

Product Name: Gramoxone

  • Active Ingredient(s)
    • PARAQUAT
      • Unknown

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 III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Blue Heeler

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6.5

7. Weight (provide a range if necessary )

45

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Vomiting
  • General
    • Symptom - Dehydration
  • Respiratory System
    • Symptom - Laboured breathing
  • Renal System
    • Symptom - Renal failure
  • Blood
    • Symptom - Hyperglycemia
    • Symptom - Blood urea nitrogen increased
    • Specify - BUN increase
    • Symptom - Hypokalemia
    • Symptom - Hyponatremia
    • Specify - Low sodium
    • Symptom - Other
    • Specify - Low chloride
    • Symptom - Hyperphosphatemia
    • Specify - Elevated phosphorus
  • Liver
    • Symptom - Elevated liver enzymes
  • Blood
    • Symptom - Leukocytosis
    • Specify - Elevated Monocyte count
    • Symptom - Leukopenia
    • Specify - Low Lymphocyte count
  • Renal System
    • Symptom - Proteinuria
    • Specify - Mild elevations in Total Protein, Albumin, and Globulins
  • Blood
    • Symptom - Other
    • Specify - Mild elevations in HCT, and Hgb
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

15. Outcome of the incident

Died

16. How was the animal exposed?

Other / Autre

specify No witnessed exposure. Dog was locked in shed for 1.5 days; product was in the shed along with others. Presumed exposure.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

1-16243665: The reporter, a (job title), called on 6/6/08 to report possible ingestion by a 6.5 year old dog of a product containing the active ingredient Paraquat. According to the reporter, the dog had accidentally been locked in a shed for 1.5 days. While there was no witnessed exposure, the product had been in the shed along with other products. The dog had presented to the veterinary clinic on 6/6 with lethargy, anorexia, vomiting, bloodwork abnormalities, labored breathing, and had been diagnosed with renal failure. BUN was elevated (68, 27 high normal), as was Creatinine (3.2, high normal 1.8), Phosphorus (11.1, high normal 6.8), and glucose (168, high normal 143). There were mild elevations in TP (8.9, high normal 8.2), Albumin (4.3, high normal 4), and Globulins (4.6, high normal 4.5). Liver enzymes were normal, but Amylase was elevated at 2006 (high 1500). Electrolytes were all low (Sodium at 142, low normal 144; Potassium at 2.3, low normal 3.5; and Chloride at 97, low normal 109). Mild elevations in HCT (56.8, high 55) and Hgb (20.1, high 18) were present. The Lymphocyte count was low (0.48, range 0.50-4.90) and the Monocyte count was elevated (2.24, range 0.3-2). At the time of the call, the dog had been bathed and placed on IV fluids. The safety profile of the product was discussed in terms of its potential for causing acute pulmonary edema and acute renal failure. A recommendation was made to obtain baseline chest x-rays and then recheck them periodically, as the edema could be delayed. It was also recommended to rehydrate the dog with IV fluids at 2-3 times maintenance rate, monitoring for the potential for oliguric renal failure. Anti-emetics and nutritional support were further recommended. The reporter was encouraged to consider that, since there was no witnessed exposure, other products in the shed or even other illnesses could be playing a part in the dog┐s symptoms was well. A follow-up call revealed the dog had passed away the evening of 6/7.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The dog was locked in a shed for 1.5 days in summer. There is no evidence that this particular product was accessible to the dog.