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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: 2015-6296

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 2015KP302

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

Adresse: 2920 Matheson Boulevard

Ville: Missisaugua

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.

19-OCT-15

5. Lieu de l'incident.

Pays: UNITED STATES

État: UNKNOWN

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

02-JUL-15

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 Collar - Large Dog

  • Matière active
    • Flumethrin
    • IMIDACLOPRID
      • Garantie/concentration 10 %

7. b) Type de formulation.

Autre (préciser)

Collar

Renseignments sur l'application

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

Oui

9. Dose d'application.

1

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 12-Jun-2015, a 2 year old, 62 pound, neutered, male, German Shepherd Dog canine, in good condition with no known concomitant medical conditions, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck 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?

Oui

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Autre

2.Type d'animal touché

Dog / Chien

3. Race

German Shepherd

4. Nombre d'animaux touchés

1

5. Sexe:

Homme

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

2

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

62

lbs

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

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

11. Énumérer tous les symptômes

Système

  • General
    • Symptôme - Mort
    • Symptôme - Hyperthermie
  • Sang
    • Symptôme - Leucoytose
  • Système gastro-intestinal
    • Symptôme - Formation d'écume buccale
  • Systèmes nerveux et musculaire
    • Symptôme - Désorientation
  • General
    • Symptôme - Lethargie
  • Système gastro-intestinal
    • Symptôme - Anorexie
  • General
    • Symptôme - Adipsie
  • Systèmes nerveux et musculaire
    • Symptôme - Crise
  • Système gastro-intestinal
    • Symptôme - Vomit

12. Quelle a été la durée des symptômes?

>24 hrs <=3 days / >24 h <=3 jours

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?

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 3-Jul-2015, the dog was disoriented, lethargic, anorexic, adipsic and was having seizure like activity. The dog was examined by an emergency veterinarian and was febrile (105.2). The collar was removed, the dog was admitted and bloodwork was performed. The dog had an elevated white blood cell count. The dog was placed on intravenous fluids and was cooled down in an unspecified manner due to the high body temperature. The dog continued to have seizures. On 4-Jul-2015, the dog was given an unspecified type of sedation. The seizures stopped. Approximately 6 hours post administration of the sedative the dog died. A necropsy was not performed. No further information is expected. Case is closed. Follow up received on 6th Jun 2015:On 3-Jul-2015, the dog was disoriented, lethargic, anorexic, adipsic and was having seizure like activity (chewing gum fits). The dog was examined by an emergency veterinarian and was febrile (105.2). The collar was removed, the dog was admitted and bloodwork was performed. The dog had an elevated white blood cell count. The dog was placed on intravenous fluids, an unspecified dose of vitamin B complex and was cooled down in an unspecified manner due to the high body temperature. The dog had a seizure (chewing gum fits) stopped spontaneously. On 4-Jul-2015, the dog started vomiting. The dog was given an unspecified dose of maropitant citrate. Approximately 3 hours post administration of the maropitant citrate, the dog started having a seizure (chewing gum fits). Approximately 7 hours after this seizure episode started, the dog was given an unspecified type of sedation and kept sedated to control seizure activity. Approximately 1 hour post administration of the sedative, the dog was found dead. A necropsy was not performed. No further information is expected. Case is closed.


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

Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause death either. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Furthermore the product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. Overdose of 5 collars around the neck of 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 did not cause serious signs either. Even with oral product exposure, seizures are not expected. Merely gastrointestinal signs would be possible. However, no oral exposure to product reported. Other reported signs, foaming, disorientation, lethargy, anorexia and adipsia may have occurred due to seizures. Reported signs, febrile and and elevated white blood cell count are not expected after product application as signs are not in line with products pharmaco-toxicological profile. Signs rather be related to other, e.g. infectious cause or intoxication. Vomiting is unspecific sign and may have numerous other causes as well or may be consequence of other signs. Time to onset is too long for all signs and product was tolerated without any problems for more than 3 weeks before first signs were reported. Sudden appearance of serious signs and especially death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Furthermore dog died after sedation, thus other causes must be considered first. Considering the known product profile and time to onset, sufficient information exists to conclude that the product did not cause the event and product involvement was ruled out.