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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: 2017-4160

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: UUSA-BAYERBAH-2017-US0035175

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.


5. Lieu de l'incident.



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.

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
      • Garantie/concentration 10 %

7. b) Type de formulation.

Autre (préciser)


Renseignments sur l'application

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


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.)

An 8 year old, 22.8 pound, neutered, male, Terrier (Rat) canine, in unknown 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?


Sous-formulaire III : Animal domestique

1. Source de la déclaration

Propriétaire de l'animal

2.Type d'animal touché

Dog / Chien

3. Race

Terrier (Rat)

4. Nombre d'animaux touchés


5. Sexe:


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


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



8. Voie(s) d'exposition:


9. Durée de l'exposition?

>3 days <=1 wk / >3 jours <=1 sem

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

>3 days <=1 wk / >3 jours <=1 sem

11. Énumérer tous les symptômes


  • Systèmes nerveux et musculaire
    • Symptôme - Contraction musculaire
  • General
    • Symptôme - Comportement anormal
  • Systèmes nerveux et musculaire
    • Symptôme - Crise
  • Système gastro-intestinal
    • Symptôme - Vomit
  • Peau
    • Symptôme -
  • General
    • Symptôme - Dépendant
  • Systèmes nerveux et musculaire
    • Symptôme - Autre
    • Specify - Proprioception deficit
  • General
    • Symptôme - Autre
    • Specify - Hyperaemic mucous membrane
    • Symptôme - Lethargie
  • Systèmes nerveux et musculaire
    • Symptôme - Tremblement
  • General
    • Symptôme - Hypothermie
  • Système rénal
    • Symptôme - Insuffisance rénale
  • General
    • Symptôme - Mort
  • Systèmes nerveux et musculaire
    • Symptôme - Difficulté de marcher
    • Specify - dragging of hind paws

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.


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


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


15. Issue de l'incident


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 16-Jun-2017, an 8 year old, 22.8 pound, neutered, male, Terrier (Rat) canine, in unknown condition, with no known concomitant medical conditions, who was administered 250 mg methocarbamol every 12 hours since approximately 2015, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. The version date on the tin packaging of V 01/2016 is not consistent with distributed product and the tin was also a different color white on the outside than tins at the veterinary clinic (possible counterfeit). On 17-Jun-2017, the canine vomited a large amount after getting into the cat's food. On 18-Jun-2017, the canine exhibited generalized pruritus and clingy behavior. On 19-Jun-2017, the canine vomited clear fluid once and resolved and exhibited dragging of hind paws(proprioceptive deficits), anorexia, hyperemic oral mucosa, and lethargy. The collar was removed and the canine was bathed in an liquid dish soap. Immediately post bathing the canine began to tremble and his temperature was 97 degrees Fahrenheit. One hour post onset the trembling resolved. The canine was evaluated by a veterinarian. No known temperature was taken. The canine was administered injections of diphenhydramine and maropitant citrate and was started on an oral dog toothpaste. Approximately 4 hours post the initial bath, the canine was bathed again in a human baby shampoo on the recommendations of the veterinarian. On 20-Jun-2017, the canine exhibited skin fasciculation when touched and growled twice at the owner. The canine was examined by a veterinarian. Blood work was performed; the results were unknown. The canine was hospitalized and started on a constant rate of unspecified fluids intravenously. The canine had a seizure and was administered an unspecified dose of valium via an unknown route. The canine died approximately 10 minutes after the onset of the seizure. It was unknown if a necropsy examination was performed. Follow-Up Received on 23rd Jun 2017: No necropsy was performed. On 22Jun2017, the bloodwork returned and the veterinarian diagnosed the dog with acute kidney failure.

À être déterminé par le titulaire

Classification selon la gravité (s'il y a plus d'une catégorie possible, veuillez choisir la plus grave)


19. Donner des renseignements additionnels ici

O - Unclassifiable/unassessable Reported digestive sign such as vomiting is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Though mild gastrointestinal signs may occur shortly after product application, vomiting in this case rather related to ingestion of cat food. Pruritus on other than the application site is not typically seen with topical product administration. Other causes (e.g. allergies) have to be considered as well. Initial pruritus may represent a reaction to the collar in a sensitive animal. Reported behavioural sign such as being clingy may occur initially after collar administration. Time to onset short for the signs. Reported hyperemic oral mucosa is unspecific, unusual and are not expected based on the pharmacological product profile. Reported dragging of hind paws is not typically seen with appropriate topical product administration. No oral product exposure reported. Considering short time to onset, these signs may reflect a mere behavioural reaction to the collar than a true systemic condition. The collar was removed and bathed. Subsequent trembling and hypothermia were likely related to the bathing. Skin fasciculation was observed after collar removal and bathing and thus is not considered product related. The same applies for growling. Dog received treatments and developed seizures after that. 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. But seizures/convulsions were reported in connection with product use in dogs and were requested by authorities to be content of the EU SPC. However, it is known that overdose of 5 collars around the neck of adult dogs for an 8 months period and in 7 week old puppies for a 6 months period did not cause serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application. Any action or treatment may trigger seizures in an animal with a respective disposition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. In this case, use of another drug e.g. methacarbamol role of which causing seizure can not be ruled out completely. Death and later diagnosed acute renal failure are not expected following appropriate topical product application as inconsistent with products pharmacological profile. Fasciculation, seizure, death and diagnosed acute renal failure occurred after collar removal and thus were not product related. Animal involved in this case likely died due to diagnosed acute renal failure. Although first signs started shortly after product application, a relation with seizure, renal disorder and death can be ruled out. In the end, the case was considered unassessable.