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Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2019-7170

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0069590 (Report 612286)

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 un animal domestique

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

27-NOV-19

5. Lieu de l'incident.

Pays: UNITED STATES

État: VIRGINIA

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

18-OCT-19

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. 11556-155

Nom du produit: Seresto Small Dog collar

Matière active
- FLUMETHRIN
  - Garantie/concentration 4.5 %
- IMIDACLOPRID
  - Garantie/concentration 10 %

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

Nom du produit: K9advantix 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. 11556-142

Nom du produit: K9advantix II medium 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: Advantage Treatment Shampoo for dogs and puppies

Matière active
- N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
  - Garantie/concentration .479 %
- PIPERONYL BUTOXIDE
  - Garantie/concentration .3 %
- PYRETHRINS
  - Garantie/concentration .15 %

7. b) Type de formulation.

Liquide

Autre (préciser)

COLLAR

Renseignments sur l'application

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

Oui

9. Dose d'application.

Autres unités: COLLAR

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 01-Jun-2019, a 3 year old, approximately 11 pound, neutered, male, Spitz - German Pomeranian/Chihuahua crossbred dog, in unknown condition, with concomitant medical condition of fleas, that was bathed with Advantage ______ every 2 weeks since Mar-2019, and that was administered an unspecified medication orally since an unknown date in 2019, was administered 1 tube of K9 Advantix II Medium Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. On approximately 01-Jul-2019, the dog had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner. On 18-Oct-2019 the dog was administered 1 tube of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner.

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

Propriétaire de l'animal

2.Type d'animal touché

Dog / Chien

3. Race

Spitz - German Pomeranian/Chihuahua crossbred

4. Nombre d'animaux touchés

5. Sexe:

Homme

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

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

4.99

8. Voie(s) d'exposition:

Cutanée

9. Durée de l'exposition?

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

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

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

11. Énumérer tous les symptômes

Système

General
- Symptôme - Lethargie

Systèmes nerveux et musculaire
- Symptôme - Difficulté de marcher

General
- Symptôme - Mort

Système gastro-intestinal
- Symptôme - Perte de poids

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.

Non

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

Non

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

15. Issue de l'incident

Mort

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

Treatment / Traitement

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

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

On approximately 01-Sep-2019, the collar was removed. On 18-Oct-2019, the dog exhibited weight loss to approximately 10 pounds On 07-Nov-2019, the dog exhibited lethargy and difficulty walking. Approximately 8 hours post onset, the dog died. The dog was not evaluated by a veterinarian, and no necropsy was performed. No further information is expected. This case is closed. Updated information 27-Nov-2019: Correction of product: Dog was bathed with MGK Advantage Treatment Shampoo for Dogs and Puppies (unspecified) every 2 weeks since Mar-2019.

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

Seresto Small Dog collar: Reported weight loss, lethargy, walking difficulty and further reported death occurred long time after collar removal thus, not related to the product. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious sign like death. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Other unrelated causes are likely in this case. Overall, product involvement is considered unlikely. K9advantix II small dog: Weight loss is not expected after product application. Though permethrin has the potential to cause slight neurological disorder like walking difficulty in walking in particular susceptible animals, it is not expected as time to onset is long. Lethargy is an unspecific sign and may be associated with walking difficulty. Death is not expected after topical product application as it is inconsistent with the pharmaco-toxicological product profile. Time to onset is more than 12 hours, therefore an allergic/anaphylactic-type reaction can be ruled out. Other causes are more probable in this dog. Time to onset is long. Overall, a product relation is considered unlikely. K9advantix II medium dog: Weight loss is not expected after product application. Though permethrin has the potential to cause slight neurological disorder like walking difficulty in walking in particular susceptible animals, it is not expected as time to onset is long. Lethargy is an unspecific sign and may be associated with walking difficulty. Death is not expected after topical product application as it is inconsistent with the pharmaco-toxicological product profile. Time to onset is more than 12 hours, therefore an allergic/anaphylactic-type reaction can be ruled out. Other causes are more probable in this dog. Time to onset is long. Overall, a product relation is considered unlikely. MGK Advantage Treatment Shampoo for Dogs and Puppies: None of the signs expected following appropriate use of the product. Even in case of oral ingestion would not expect severe sign like death. Product has a wide margin of safety. Moreover, in case of oral ingestion only small amounts are ingested and rather cause mild digestive tract disorders. In this case no oral ingestion witnessed or suspected. Product was well tolerated on a regular basis every two weeks over a period of approximately 7 months. Other products were administered concomitantly. Signs non-specific and rather related to impending death. Time to onset in this case unknown, since previous treatment date unknown. No necropsy performed. Overall, product relation rather unlikely, but due to insufficient information, product relation is considered unclassifiable.