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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-2005

2. Registrant Information.

Registrant Reference Number: PROSAR 1-22064278

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.

26-MAR-10

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

26-MAR-10

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. 100-1217

Product Name: Gramoxone Inteon

  • Active Ingredient(s)
    • PARAQUAT
      • Guarantee/concentration 30.1 %

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).

The diluted product was sprayed on weeds in the animal owner's yard on 3/20/10. Dilution ratio is not known.

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

Basset Hound

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Salivating excessively
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Mouth Irritation
    • Specify - Oral ulcers
    • Symptom - Vomiting
  • Renal System
    • Symptom - Creatinine increased
    • Specify - Creatinine increase
  • Respiratory System
    • Symptom - Laboured breathing
    • Symptom - Other
    • Specify - Increased interstitial pattern in lungs
  • General
    • Symptom - Death
  • Blood
    • Symptom - Blood urea nitrogen increased
    • Specify - BUN increased
    • Symptom - Hyperphosphatemia

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?

8

Day(s) / Jour(s)

15. Outcome of the incident

Died

16. How was the animal exposed?

Other / Autre

specify There was no witnessed exposure. It was presumed the dogs may have ingested treated vegetation.

17. Provide any additional details about the incident

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

1-22064278: The reporter, a veterinarian, notified the registrant on 3/26/10 of the exposure of 3 dogs to an herbicide product containing Paraquat Dichloride. According to the reporter, the product in question had been diluted and applied on 3/20/10. There was no witnessed exposure of the dogs to the product; however, it was presumed they may have ingested treated vegetation. All dogs belonged to the same family. The first dog, a male Basset Hound (first subform III, unspecified age), presented to the reporter with hypersalivation, vomiting, oral ulcers, anorexia, azotemia (elevated BUN and Creatinine) and hyperphosphatemia. The second dog, a Maltese (second subform III, unspecified sex and age), presented on 3/26 with signs of lethargy, anorexia, azotemia (elevated BUN and Creatinine) and hyperphosphatemia. The third dog, a Basset Hound (third subform III, unspecified age and sex), presented with hypersalivation; no bloodwork was done on this dog and renal values were presumed to be similarly elevated. Target organs (lungs, renal) of Paraquat toxicosis were discussed along with treatment recommendations (avoid oxygen therapy if possible, maintain urine production, monitor pulmonary function via x-rays, and other supportive care as needed). Decontamination was deemed to not be viable given the long delay (up to 6 days) since the presumed exposure. Several follow-up calls were placed to the reporter. All three dogs had been placed on IV fluids, Sucralfate and Cimetidine. By 3/29/10, the first patient (first subform III) had developed increased respiratory effort in addition to persistent anorexia and vomiting. He had been given a guarded prognosis. The other two dogs had improved and were urinating well. A recommendation was made to take x-rays on the dog with respiratory symptoms. Irreversible respiratory failure from pulmonary edema/fibrosis is the major cause of death in Paraquat toxicosis. The reporter was also advised to treat with hepatoprotectants since liver damage may also occur. By 4/2/10, the first patient¿s (first subform III) respiratory symptoms had worsened. X-rays had revealed a rough, interstitial pattern. His oral ulcers were improved after treatment with pain medications and oral flushing. He was eating a slurry of canned food and water. He was due to be discharged that day as the owners wanted him at home ¿ especially in light of the guarded prognosis. The other two dogs had been discharged previously and were doing well at home. All three dogs were on hepatoprotectants and GI protectants. During the last follow-up call on 4/16/10, the reporter revealed the first patient (first subform III) had died shortly after being discharged. The other two dogs continued to do well, and had not developed any respiratory issues. Their renal values were normal upon recheck (4/15/10).


To be determined by Registrant

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

Death

19. Provide supplemental information here

There was no witnessed exposure of the dogs to the product; however, it was presumed they may have ingested treated vegetation. Patient symptoms are consistent with exposure to the concentrated product or to larger amounts of fresh, wet diluted product. There is no residential use on the label for Paraquat products.

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Maltese

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • Renal System
    • Symptom - Creatinine increased
    • Specify - Creatinine increased
    • Symptom - Other
    • Specify - BUN increased
  • Blood
    • Symptom - Hyperphosphatemia

12. How long did the symptoms last?

Unknown / Inconnu

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?

Unknown

15. Outcome of the incident

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Other / Autre

specify There was no witnessed exposure. It was presumed the dogs may have ingested treated vegetation.

17. Provide any additional details about the incident

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

1-22064278: The reporter, a veterinarian, notified the registrant on 3/26/10 of the exposure of 3 dogs to an herbicide product containing Paraquat Dichloride. According to the reporter, the product in question had been diluted and applied on 3/20/10. There was no witnessed exposure of the dogs to the product; however, it was presumed they may have ingested treated vegetation. All dogs belonged to the same family. The first dog, a male Basset Hound (first subform III, unspecified age), presented to the reporter with hypersalivation, vomiting, oral ulcers, anorexia, azotemia (elevated BUN and Creatinine) and hyperphosphatemia. The second dog, a Maltese (second subform III, unspecified sex and age), presented on 3/26 with signs of lethargy, anorexia, azotemia (elevated BUN and Creatinine) and hyperphosphatemia. The third dog, a Basset Hound (third subform III, unspecified age and sex), presented with hypersalivation; no bloodwork was done and renal values were presumed to be similarly elevated. Target organs (lungs, renal) of Paraquat toxicosis were discussed along with treatment recommendations (avoid oxygen therapy if possible, maintain urine production, monitor pulmonary function via x-rays, and other supportive care as needed). Decontamination was deemed to not be viable given the long delay (up to 6 days) since the presumed exposure. Several follow-up calls were placed to the reporter. All three dogs had been placed on IV fluids, Sucralfate and Cimetidine. By 3/29/10, the first patient (first subform III) had developed increased respiratory effort in addition to persistent anorexia and vomiting. He had been given a guarded prognosis. The other two dogs had improved and were urinating well. A recommendation was made to take x-rays on the dog with respiratory symptoms. Irreversible respiratory failure from pulmonary edema/fibrosis is the major cause of death in Paraquat toxicosis. The reporter was also advised to treat with hepatoprotectants since liver damage may also occur. By 4/2/10, the first patient¿s (first subform III) respiratory symptoms had worsened. X-rays had revealed a rough, interstitial pattern. His oral ulcers were improved after treatment with pain medications and oral flushing. He was eating a slurry of canned food and water. He was due to be discharged that day as the owners wanted him at home ¿ especially in light of the guarded prognosis. The other two dogs had been discharged previously and were doing well at home. All three dogs were on hepatoprotectants and GI protectants. During the last follow-up call on 4/16/10, the reporter revealed the first patient (first subform III) had died shortly after being discharged. The other two dogs continued to do well, and had not developed any respiratory issues. Their renal values were normal upon recheck (4/15/10).


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

There was no witnessed exposure of the dogs to the product; however, it was presumed they may have ingested treated vegetation. Patient symptoms are consistent with exposure to the concentrated product or to larger amounts of fresh, wet diluted product. There is no residential use on the label for Paraquat products.

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Basset Hound

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Salivating excessively

12. How long did the symptoms last?

Unknown / Inconnu

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?

Unknown

15. Outcome of the incident

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Other / Autre

specify There was no witnessed exposure. It was presumed the dogs may have ingested treated vegetation.

17. Provide any additional details about the incident

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

1-22064278: The reporter, a veterinarian, notified the registrant on 3/26/10 of the exposure of 3 dogs to an herbicide product containing Paraquat Dichloride. According to the reporter, the product in question had been diluted and applied on 3/20/10. There was no witnessed exposure of the dogs to the product; however, it was presumed they may have ingested treated vegetation. All dogs belonged to the same family. The first dog, a male Basset Hound (first subform III, unspecified age), presented to the reporter with hypersalivation, vomiting, oral ulcers, anorexia, azotemia (elevated BUN and Creatinine) and hyperphosphatemia. The second dog, a Maltese (second subform III, unspecified sex and age), presented on 3/26 with signs of lethargy, anorexia, azotemia (elevated BUN and Creatinine) and hyperphosphatemia. The third dog, a Basset Hound (third subform III, unspecified age and sex), presented with hypersalivation; no bloodwork was done and renal values were presumed to be similarly elevated. Target organs (lungs, renal) of Paraquat toxicosis were discussed along with treatment recommendations (avoid oxygen therapy if possible, maintain urine production, monitor pulmonary function via x-rays, and other supportive care as needed). Decontamination was deemed to not be viable given the long delay (up to 6 days) since the presumed exposure. Several follow-up calls were placed to the reporter. All three dogs had been placed on IV fluids, Sucralfate and Cimetidine. By 3/29/10, the first patient (first subform III) had developed increased respiratory effort in addition to persistent anorexia and vomiting. He had been given a guarded prognosis. The other two dogs had improved and were urinating well. A recommendation was made to take x-rays on the dog with respiratory symptoms. Irreversible respiratory failure from pulmonary edema/fibrosis is the major cause of death in Paraquat toxicosis. The reporter was also advised to treat with hepatoprotectants since liver damage may also occur. By 4/2/10, the first patient¿s (first subform III) respiratory symptoms had worsened. X-rays had revealed a rough, interstitial pattern. His oral ulcers were improved after treatment with pain medications and oral flushing. He was eating a slurry of canned food and water. He was due to be discharged that day as the owners wanted him at home ¿ especially in light of the guarded prognosis. The other two dogs had been discharged previously and were doing well at home. All three dogs were on hepatoprotectants and GI protectants. During the last follow-up call on 4/16/10, the reporter revealed the first patient (first subform III) had died shortly after being discharged. The other two dogs continued to do well, and had not developed any respiratory issues. Their renal values were normal upon recheck (4/15/10).


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

There was no witnessed exposure of the dogs to the product; however, it was presumed they may have ingested treated vegetation. Patient symptoms are consistent with exposure to the concentrated product or to larger amounts of fresh, wet diluted product. There is no residential use on the label for Paraquat products.