Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2010-2005

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: PROSAR 1-22064278

Nom du titulaire (nom légal complet, aucune abbréviation): Syngenta Crop Protection Canada, Inc.

Adresse: 140 Research Lane, Research Park

Ville: Guelph

État: Ontario

Pays: Canada

Code postal /Zip: N1G4Z3

3.Choisir le (les) sous-formulaire(s) correspondant à l'incident.

Incident chez un animal domestique

4. Date à laquelle le titulaire d'homologation a été informé pour la première fois de l'incident.

26-MAR-10

5. Lieu de l'incident.

Pays: UNITED STATES

État: TEXAS

6. Date de la première observation de l'incident.

26-MAR-10

Description du produit

7. a) Donner le nom de la matière active et, si disponibles, le numéro d'homologation et le nom du produit (incluant tous les mélanges). Si le produit n'est pas homologué, donner le numéro de la demande d'homologation.

Matière(s) active(s)

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ARLA No d'homologation       ARLA No de la demande d'homologation       EPA No d'homologation. 100-1217

Nom du produit: Gramoxone Inteon

• Matière active
  • PARAQUAT
    • Garantie/concentration 30.1 %

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7. b) Type de formulation.

Liquide

Renseignments sur l'application

8. Est-ce que le produit a été appliqué?

Oui

9. Dose d'application.

Inconnu

10. Site d'application (choisir tout ce qui s'applique).

Site: Res. - Out Home / Rés - à l'ext.maison

11. Donner tout renseignement additionnel concernant l'application (comment le produit a été appliqué, la quantité utilisée, la superficie de la zone traitée, etc.)

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

À être déterminé par le titulaire

12. Selon vous, le produit a-t-il été utilisé en conformité avec le mode d'emploi de L'étiquette?

Inconnu

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Professionnel de la santé

2.Type d'animal touché

Dog / Chien

3. Race

Basset Hound

4. Nombre d'animaux touchés

1

5. Sexe:

Homme

6. Âge (fournir un ordre de grandeur si nécessaire)

Inconnu

7. Poids (fournir un ordre de grandeur si nécessaire)

Inconnu

8. Voie(s) d'exposition:

Inconnu

9. Durée de l'exposition?

Unknown / Inconnu

10. Temps écoulé entre l'exposition et l'apparition des symptômes

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

11. Énumérer tous les symptômes

Système

• Système gastro-intestinal
  • Symptôme - Salivation excessive

• General
  • Symptôme - Lethargie

• Système gastro-intestinal
  • Symptôme - Anorexie
  • Symptôme - rritation de la bouche
  • Specify - Oral ulcers
  • Symptôme - Vomit

• Système rénal
  • Symptôme - Augmentation du taux de créatinine
  • Specify - Creatinine increase

• Système respiratoire
  • Symptôme - Respiration difficile
  • Symptôme - Autre
  • Specify - Increased interstitial pattern in lungs

• General
  • Symptôme - Mort

• Sang
  • Symptôme - Azote uréique du sang augmenté
  • Specify - BUN increased
  • Symptôme - Hyperphosphatémie

12. Quelle a été la durée des symptômes?

Persisted until death

13. Des soins médicaux ont-ils été prodigués? Donner les détails à la question 17.

Oui

14. a) Est-ce que l'animal a-t-il été hospitalisé?

Oui

14. b) Combien de temps l'animal était-il hospitalisé?

8

Day(s) / Jour(s)

15. Issue de l'incident

Mort

16. De quelle manière l'animal a-t-il été exposé?

Other / Autre

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

17. Donnez tout détail additionnel au sujet de l'incident

(p.ex. description des symptômes tels que la fréquence et la gravité

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).

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À être déterminé par le titulaire

Classification selon la gravité (s'il y a plus d'une catégorie possible, veuillez choisir la plus grave)

Mort

19. Donner des renseignements additionnels ici

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.

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Professionnel de la santé

2.Type d'animal touché

Dog / Chien

3. Race

Maltese

4. Nombre d'animaux touchés

1

5. Sexe:

Inconnu

6. Âge (fournir un ordre de grandeur si nécessaire)

Inconnu

7. Poids (fournir un ordre de grandeur si nécessaire)

Inconnu

8. Voie(s) d'exposition:

Inconnu

9. Durée de l'exposition?

Unknown / Inconnu

10. Temps écoulé entre l'exposition et l'apparition des symptômes

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

11. Énumérer tous les symptômes

Système

• General
  • Symptôme - Lethargie

• Système gastro-intestinal
  • Symptôme - Anorexie

• Système rénal
  • Symptôme - Augmentation du taux de créatinine
  • Specify - Creatinine increased
  • Symptôme - Autre
  • Specify - BUN increased

• Sang
  • Symptôme - Hyperphosphatémie

12. Quelle a été la durée des symptômes?

Unknown / Inconnu

13. Des soins médicaux ont-ils été prodigués? Donner les détails à la question 17.

Oui

14. a) Est-ce que l'animal a-t-il été hospitalisé?

Oui

14. b) Combien de temps l'animal était-il hospitalisé?

Inconnu

15. Issue de l'incident

Fully Recovered / Complètement rétabli

16. De quelle manière l'animal a-t-il été exposé?

Other / Autre

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

17. Donnez tout détail additionnel au sujet de l'incident

(p.ex. description des symptômes tels que la fréquence et la gravité

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).

---

À être déterminé par le titulaire

Classification selon la gravité (s'il y a plus d'une catégorie possible, veuillez choisir la plus grave)

Modérée

19. Donner des renseignements additionnels ici

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.

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Professionnel de la santé

2.Type d'animal touché

Dog / Chien

3. Race

Basset Hound

4. Nombre d'animaux touchés

1

5. Sexe:

Inconnu

6. Âge (fournir un ordre de grandeur si nécessaire)

Inconnu

7. Poids (fournir un ordre de grandeur si nécessaire)

Inconnu

8. Voie(s) d'exposition:

Inconnu

9. Durée de l'exposition?

Unknown / Inconnu

10. Temps écoulé entre l'exposition et l'apparition des symptômes

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

11. Énumérer tous les symptômes

Système

• Système gastro-intestinal
  • Symptôme - Salivation excessive

12. Quelle a été la durée des symptômes?

Unknown / Inconnu

13. Des soins médicaux ont-ils été prodigués? Donner les détails à la question 17.

Oui

14. a) Est-ce que l'animal a-t-il été hospitalisé?

Oui

14. b) Combien de temps l'animal était-il hospitalisé?

Inconnu

15. Issue de l'incident

Fully Recovered / Complètement rétabli

16. De quelle manière l'animal a-t-il été exposé?

Other / Autre

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

17. Donnez tout détail additionnel au sujet de l'incident

(p.ex. description des symptômes tels que la fréquence et la gravité

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).

---

À être déterminé par le titulaire

Classification selon la gravité (s'il y a plus d'une catégorie possible, veuillez choisir la plus grave)

Modérée

19. Donner des renseignements additionnels ici

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.