Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2016-2741

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 2016KP059

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.

04-MAY-16

5. Lieu de l'incident.

Pays: UNITED STATES

État: UNKNOWN

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

15-DEC-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)

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ARLA No d'homologation       ARLA No de la demande d'homologation       EPA No d'homologation. 11556-155

Nom du produit: Seresto Collar - Unknown

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

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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 15-Sep-2015, a 15 month old, 23 pound,neutered, male, Pug canine, in good condition, with no known concomitant medical conditions, had 1 Seresto Dog(unspecified) (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?

Inconnu

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Autre

2.Type d'animal touché

Dog / Chien

3. Race

Pug

4. Nombre d'animaux touchés

1

5. Sexe:

Homme

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

1.3

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

23

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

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

11. Énumérer tous les symptômes

Système

• General
  • Symptôme - Mort
  • Symptôme - Lethargie

• Système gastro-intestinal
  • Symptôme - Salivation excessive

• Systèmes nerveux et musculaire
  • Symptôme - Tremblements musculaires
  • Symptôme - Convulsions
  • Symptôme - Crise

• Sang
  • Symptôme - Leucoytose
  • Symptôme - Leucoytose
  • Specify - Neutrophilia
  • Symptôme - Autre
  • Specify - Hypophosphataemia

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?

Oui

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

1

Day(s) / Jour(s)

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 15Dec2015, the dog exhibited lethargy. The dog was examined by a veterinarian, tested positive for lyme disease, was given a lyme vaccine and started on minocycline. The dog returned to the clinic approximately 2 hours later, foaming at the mouth and shaking, and was treated with dexamethasone and diphenhydramine injections. On 16Dec2015, the dog returned to the clinic seizuring, foaming mouth, and convulsing. The dog had additional bloodwork performed the results were unknown. The dog was started on zonisamide. On 17Dec2015 the dog died at home. No necropsy was performed. No further information is expected; this case is closed. Follow up received on 14 Jan 2016: On 15-Sep-2015, a 15 month old, 23 pound, neutered, male, Pug canine, in good condition, with no known concomitant medical conditions, had 1 Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 15 Dec 2015, the dog exhibited lethargy. The dog was examined by a veterinarian, tested positive for Lyme disease, was given a Lyme vaccine and started on minocycline. Approximately 1 hour later, the dog had an episode of foaming at the mouth and shaking. He was returned to the clinic, where he was examined and found to be normal. He was treated with dexamethasone and diphenhydramine injections. On 16 Dec 2015, the dog had another similar episode during the day. That evening, the dog had a third episode. He was returned to the hospital. While at the hospital, the dog had a fourth episode where the dog initially was shaking, then had facial twitching, foaming at the mouth, and a seizure. Blood work was performed and the only abnormalities were decreased phosphorus, slight leukocytosis, neutrophilia and monocytosis. Toxic exposure to something in the household could not be ruled out. The dog was started on zonisamide. On 17 Dec 2015 the dog died at home. No necropsy was performed. No further information is expected; this case is closed.

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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

Lethargy is an unspecific sign and may have multiple possible causes in an animal. Lyme disease is a tick borne bacterial disease. In this case, no ticks seen on dog. Even as per the labelled claim of efficacy of the product, attachment of single ticks and even sucking of blood and thus transfer of tick borne diseases cannot be excluded while the collar is worn, especially when infestation pressure is high. Foaming at the mouth and shaking are not anticipated with appropriate topical product administration. Multiple episodes of these signs along with facial twitching were likely introducing the subsequent seizure. The product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration. Even with oral product exposure, which was anyway not reported in this case, only transient gastrointestinal signs would be expected. The abnormal blood parameters are unexpected may be associated with other reported signs. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. In this case, Lyme disease, other medications administered (including a vaccine) and the suspected toxic exposure are more likely to have contributed to the signs. Finally time to onset was exceptionally long (3 months). Considering all these aspects, although no necropsy was performed, product relation was deemed to be unlikely.