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Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2011-1835

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: PROSAR Case#: 1-25496880

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 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: CANADA

État: ONTARIO

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

Inconnu

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 27428      ARLA No de la demande d'homologation       EPA No d'homologation.

Nom du produit: Demand CS Insecticide

• Matière active
  • LAMBDA-CYHALOTHRIN

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

Nom du produit: Tempo

• Matière active
  • CYFLUTHRIN

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

Nom du produit: Prelude

• Matière active
  • PERMETHRIN

7. b) Type de formulation.

Renseignments sur l'application

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

Inconnu

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.

Personne affectée

2. Renseignement démographique sur la personne affectée

Sexe: Homme

Âge: >19 <=64 yrs / >19 <=64 ans

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

Système

• Oreille
  • Symptôme - Acouphène

• Systèmes nerveux et musculaire
  • Symptôme - Mal de tête
  • Symptôme - Étourdissement
  • Symptôme - Contraction musculaire
  • Symptôme - Faiblesse musculaire

• General
  • Symptôme - Fatigue

• Systèmes nerveux et musculaire
  • Symptôme - Douleur musculaire

• Oeil
  • Symptôme - Vision floue
  • Symptôme - Difficulté de focalisation
  • Specify - delayed focusing of eyes

• Oreille
  • Symptôme - Autre
  • Specify - ear infection

4. Quelle a été la durée des symptômes?

>2 mos and <=6mos />2 mois et <=6mois

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?

Inconnu

6. b) Pendant combien de temps?

7. Scénario d'exposition

Professionnel

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

Application

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)

Inconnu

10. Voie(s) d'exposition.

Peau

Respiratoire

11.Durée de l'exposition?

Unknown / Inconnu

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

Unknown / Inconnu

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.)

1-25496880- The reporter calls to indicate possible exposure to an insecticidal product containing the active ingredient lambda-cyhalothrin. The caller also indicated he has historically worked with vaguely identified products which contained the active ingredients cyfluthrin and permethrin. The caller indicated he has worked as a pest control operator for some time (nonspecific duration). He indicates during the past two seasons he has worked with the three products but has not used personal protective equipment. He indicates possible dermal and inhalation exposure, but does not indicate a discreet incident exposure. He reports within the past three months he has developed tinnitus hearing sensitivity, headache and dizziness. He reports within the past two months twitching in his lower legs and ach weakness in his thighs. Intermittently within the past three months the caller report his vision has got out of balance which he clarifies as blurriness or delayed focusing of his eyes. He has gotten corrective lenses which he has reported has helped. The reporter indicates he has been to his general practitioner which has diagnosed an ear infection and placed him on two separate courses of antibiotics. His symptoms have not resolved. The reporter indicates he has been to two specialists (nonspecific) who have reported his hearing and ears are normal. He reports he has had two MRIs which were not diagnostic. His general practitioner has released him from work for the past month, but he states the symptoms have not improved. The reporter has indicated he is currently being referred to a toxicologist and an otolaryngologist. These appointments are pending. The caller was advised of the typical symptoms seen following dermal and inhalation exposure these active ingredients. It was recommended he continue to work with his physician to determine the cause of his current symptoms. The symptoms described are inconsistent with the toxicity profile of the listed active ingredients. Update was obtained from the caller two weeks following his initial contact with the registrant. He reports he has been to a neurologist. His primary care physician had suggested he may have carpal tunnel syndrome. The neurologist stated he did not have carpal tunnel syndrome and reached no diagnosis. The caller stated he was told there was nothing that could be done for him by this doctor. He has been to two otolaryngologists since his initial contact for the symptom of tinnitus. The first detected minor hearing loss and no structural abnormalities. He was referred to a second otolaryngologist for studies of his inner ear which, he reported, showed no abnormalities. He reports he was given one prescription (unspecified) by his family doctor for the tinnitus which did not alleviate that symptom. Current symptoms, when asked, included: ringing in ears, sick feeling in head and twitching in legs when at rest. He reports he has been on work release for one and one half month. When asked about follow up appointments or plans for his care he could provide no plan. He indicated his family doctor had wanted him to see a toxicologist at one point but he had no current appointment. He reports his family doctor indicated his chief rule outs included chemical exposure (nonspecific) and viral. The caller was advised the symptoms and time line indicated were inconsistent with the toxicity profile of the product. He was urged to continue to follow with his health care provider to determine the etiology of his current illness and most appropriate therapy. No further information is available.

À être déterminé par le titulaire

14. Classification selon la gravité.

Modérée

15. Donner des renseignements additionnels ici.

This Incident Report is being filed based on PMRAs current interpretation of the Incident Reporting Regulations. There is no direct evidence of exposure; the subject cannot describe a discrete exposure event. The symptoms described are not consistent with exposure to any of the active ingredients involved. Follow-up with the patient indicates he is suffering from a series of signs and symptoms that are inconsistent with exposure to a pyrethroid insecticide.