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Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2007-4216

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 2007May06 Canada

Nom du titulaire (nom légal complet, aucune abbréviation): Monsanto

Adresse: 800 North Lindbergh Blvd.

Ville: Saint Louis

État: Missouri

Pays: United States of America

Code postal /Zip: 63167

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

Incident chez l'humain

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

5. Lieu de l'incident.

Pays: UNITED STATES

État: NORTH CAROLINA

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

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.

ARLA No d'homologation       ARLA No de la demande d'homologation       EPA No d'homologation. 7199529

Nom du produit: Roundup Weed and Grass Killer Concentrate Plus

• Matière active
  • DIQUAT
    • Garantie/concentration .73 %
  • GLYPHOSATE (PRESENT AS ISOPROPYLAMINE SALT OR ETHANOLAMINE SALT)
    • Garantie/concentration 18 %

7. b) Type de formulation.

Liquide

Renseignments sur l'application

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

Non

9. Dose d'application.

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

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

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 II : Incident chez l'humain (Obligation d'utiliser un formulaire séparé pour chaque personne affectée)

1. Source de la déclaration.

Professionnel de la santé

2. Renseignement démographique sur la personne affectée

Sexe: Femme

Âge: >19 <=64 yrs / >19 <=64 ans

3. Énumérez tous les symptômes, au moyen des choix suivants.

Système

• Système gastro-intestinal
  • Symptôme - Vomit
  • Symptôme - Avoir des haut-le-coeur
  • Symptôme - Mal de gorge
  • Symptôme - Autre
  • Specify - swollen throat
  • Symptôme - Douleur à l'estomac
  • Symptôme - Déglutition difficile
  • Symptôme - rritation de la bouche
  • Specify - severe ulcerations of throat, esophagus and upper stomach with mild bleeding from ulcerations

• Système respiratoire
  • Symptôme -
  • Specify - coughing up bloody sputum with some pieces of skin

4. Quelle a été la durée des symptômes?

<=30 min / <=30 min

5. La personne affectée a-t-elle reçu des soins médicaux? Donner les détails à la question 13.

Oui

6. a) Est-ce que la personne a été hospitalisée?

Oui

6. b) Pendant combien de temps?

5

Day(s) / Jour(s)

7. Scénario d'exposition

Non professionnel

8. Comment l'exposition s'est-elle produite? (cocher tout ce qui s'applique)

Empoisonnement par ingestion d'un produit

9.Si l'exposition s'est produite lors du traitement ou au moment du retour dans la zone traitée, de l'équipement de protection individuelle était-il porté? (cocher tout ce qui s'applique)

10. Voie(s) d'exposition.

Orale

11.Durée de l'exposition?

<=15 min / <=15 min

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

<=30 min / <=30 min

13.Donner tout détail additionnel au sujet de l'incident (p.ex. description des symptômes tels que la fréquence et la gravité, type de soins médicaux, résultats des tests médicaux, quantité de pesticide à laquelle la personne a été exposée, 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 woman¿¿¿s 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 woman¿¿¿s 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.

À être déterminé par le titulaire

14. Classification selon la gravité.

Majeure

15. Donner des renseignements additionnels ici.

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)