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Sécurité des produits de consommation

Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2018-1249

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0006294 (Report 472651)

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

Adresse: 2920 Matheson Blvd

Ville: Mississaugua

État: ON

Pays: Canada

Code postal /Zip: L4W 5R6

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.

27-FEB-18

5. Lieu de l'incident.

Pays: UNITED STATES

État: PENNSYLVANIA

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

30-MAR-17

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)

ARLA No d'homologation       ARLA No de la demande d'homologation       EPA No d'homologation. 11556-141

Nom du produit: K9 Advantix II small dog,

  • Matière active
    • IMIDACLOPRID
      • Garantie/concentration 8.8 %
    • PERMETHRIN
      • Garantie/concentration 44 %
    • PYRIPROXYFEN
      • Garantie/concentration .44 %

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

Nom du produit: K9 Advantix II unspecified

  • Matière active
    • IMIDACLOPRID
      • Garantie/concentration 8.8 %
    • PERMETHRIN
      • Garantie/concentration 44 %
    • PYRIPROXYFEN
      • Garantie/concentration .44 %

7. b) Type de formulation.

Autre (préciser)

Spot-on

Renseignments sur l'application

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

Oui

9. Dose d'application.

1

Autres unités: pipette

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

Site: Animal / Usage sur un animal domestique

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

On approximately 20-Mar-2017, a X year old, woman, in unknown condition, with concomitant medical conditions of undifferentiated tissue disorder (auto immune disorder NOS), migraine headaches and dry eye, administered prednisone and sumatriptan since approximately 2017, was exposed to an unknown amount of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) and an unknown amount of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) when she applied it to her dogs. On approximately 20-Apr-2017, the individual was exposed to an unknown amount of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) and an unknown amount of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) when she applied it to her dogs. On approximately 20-May-2017, the individual was exposed to an unknown amount of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) and an unknown amount of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) when she applied it to her dogs. On approximately 20-Jun-2017, the individual was exposed to an unknown amount of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) and an unknown amount of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) when she applied it to her dogs. On approximately 20-Jul-2017, the individual was exposed to an unknown amount of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) and an unknown amount of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) when she applied it to her dogs.

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.

Autre

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

  • Systèmes nerveux et musculaire
    • Symptôme - Tremblement
  • Peau
    • Symptôme - Érythème
  • Systèmes nerveux et musculaire
    • Symptôme - Autre
    • Specify - Burning sensation in both arms and legs and on the face
  • General
    • Symptôme - Oedème
  • Peau
    • Symptôme - Cyanose
  • Système respiratoire
    • Symptôme - Respiration faible
  • General
    • Symptôme - Autre
    • Specify - Allergic reaction
  • Système rénal
    • Symptôme - Autre
    • Specify - Ketones in urine
  • Système gastro-intestinal
    • Symptôme - Autre
    • Specify - Clostridium difficile (disorder of gastrointestinal flora)
  • Systèmes nerveux et musculaire
    • Symptôme - Autre
    • Specify - Feeling anxious
  • Système gastro-intestinal
    • Symptôme - Nausée
    • Symptôme - Gonflement
    • Symptôme - Diarrhée
  • Peau
    • Symptôme - Autre
    • Specify - Pimples
  • Oeil
    • Symptôme - Vision floue
    • Symptôme - Vision double
  • Peau
    • Symptôme - Dermatite

4. Quelle a été la durée des symptômes?

Unknown / Inconnu

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?

Non

6. b) Pendant combien de temps?

7. Scénario d'exposition

Non professionnel

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

Contact avec la zone traitée

Temps écoulé entre l'application et l'exposition (contact) 10

Day(s) / Jour(s)

Quelle était l'activité? The woman was exposed to the products when she applied it to her dogs.

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

11.Durée de l'exposition?

>1 mo <= 6 mos / > 1 mois < = 6 mois

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

>1 wk <=1 mo / > 1 sem < = 1 mois

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.)

On approximately 30-Mar-2017, the individual experienced anxiety, nausea, bloating, increased bowel movements and diarrhea all intermittently. On an unspecified date in Apr-2017, the individual experienced pimples localized around the mouth, blurry vision and double vision when she watched television. The individual was examined by a dermatologist, was diagnosed with perioral dermatitis and started on hydrocortisone cream. On an unspecified date post onset, in approximately Apr-2017, the pimples resolved and the hydrocortisone was discontinued. On an unspecified date post discontinuation of the hydrocortisone, in approximately 2017, the pimples around the mouth reoccurred. On an unspecified date in approximately May-2017, the individual experienced tremors, erythema, facial erythema (red face), facial edema and a burning sensation in both arms and legs and on the face.On 16-Jun-2017, the individual was examined by a gastroenterologist who performed a fecal and unspecified bloodwork with unknown results. She was started on ondansetron, loperamide and colestipol. On an unspecified date in approximately Jul-2017, the individual experienced cyanotic fingers and lips (poor peripheral circulation), shortness of breath (abnormal breathing), edema with continued erythema and tremors. She was examined by a physician, then the thyroid was checked and a giardia test was performed, both with negative results. It was determined the individual had an allergic reaction and was told to continue the prednisone. Approximately 2 days post exam in Jul 2017, the individual was re-examined and started on metronidazole. On an unspecified date in approximately Aug-2017, the individual was examined by an emergency room physician and a computed tomography scan, bloodwork and a urinalysis were performed. The urinalysis revealed keytones (urine abnormalities NOS) and the individual was administered intravenous fluids. The individual was then examined by a gastroenterologist who performed unspecified tests. It was determined the individual had Clostridium difficile (disorder of gastrointestinal flora) and was started on an unspecified antibiotic. On an unspecified date in approximately Oct-2017, the individual was examined by an infectious disease physician and the individual was started on an unspecified antibiotic. On an unspecified date in approximately Nov-2017, the individual was re-examined by the infectious disease physician no known treatments were provided. On an unspecified date in approximately Feb-2018, the clinical signs improved but continued.

À être déterminé par le titulaire

14. Classification selon la gravité.

Majeure

15. Donner des renseignements additionnels ici.

Advantix: N-Unlikely: Unknown if direct or indirect exposure occurred when applying products to dogs. Reported digestive disorders are not expected after exposure to product. Time to onset is long. Moreover, no hand to mouth transfer reported. Anxiety may be associated with other reported signs. Further reported pimples localized around the mouth, blurry vision, double vision, perioral dermatitis are not anticipated after product exposure. Other causes are more probable. Further reported tremor, erythema, facial erythema, facial oedema, burning sensation in arms, legs and face, cyanotic fingers and lips, ketone bodies in urine and disorder of gastrointestinal flora on subsequent product applications are not expected either after product exposure. Moreover, signs are reported long time after each application, hence product relation can be ruled out. Finally, considering all aspects, a product connection is deemed to be unlikely. Initial assessment/causality confirmed by Medical Doctor.