Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2016-7946

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 2016KP227

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.

18-OCT-16

5. Lieu de l'incident.

Pays: UNITED STATES

État: UNKNOWN

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

29-JUN-16

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

• 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 29Jun2016, a 7 year old, 21 pound, female, Pug canine,of unknown reproductive status, in unknown condition, with no known concomitant medical conditions, had 1 SerestoSmall Dog (Flumethrin-Imidacloprid) collar placed around her 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

Pug

4. Nombre d'animaux touchés

1

5. Sexe:

Femme

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

7

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

21

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 hrs <=8 hrs / > 2 h < = 8 h

11. Énumérer tous les symptômes

Système

• General
  • Symptôme - Mort
  • Symptôme - Lethargie

• Oeil
  • Symptôme - Autre
  • Specify - Periorbital oedema

• Système respiratoire
  • Symptôme - Tachypnée

• Système gastro-intestinal
  • Symptôme - Vomit

• Oeil
  • Symptôme - Oeil rouge

• Système respiratoire
  • Symptôme - Dyspnée

• Système gastro-intestinal
  • Symptôme - Perte de poids

• Oeil
  • Symptôme - Sécrétions oculaires
  • Symptôme - Autre
  • Specify - Corneal oedema
  • Symptôme - Conjonctivite

12. Quelle a été la durée des symptômes?

Persisted until death

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?

2

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

Approximately 3 hours post product application, the canine became lethargic. On 30Jun2016, the canine developed periorbital edema, tachypnea and exhibited vomiting approximately 2 times that resolved within approximately 15 minutes. On 03Jul2016, the collar was removed. On 07Jul2016, the clinical signs continued and the canine was examined by veterinarian at an emergency clinic. The canine exhibited eye redness and was administered oxygen therapy. Follow up received on 15th July 2016: 09Jul2016, the dog was released from the hospital. 10Jul2016, the dog passed away. No necropsy was performed. Follow up received on 27th July 2016: On 22Jun2016, a 7 year old, 21 pound, female, Pug canine, of unknown reproductive status, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around her neck by the owner. Approximately 3 hours post product application, the canine became lethargic. 25Jun2016, the collar was removed. On 30Jun2016, the canine developed periorbital edema, tachypnea and exhibited vomiting approximately 2 times that resolved within approximately 15 minutes. On 07Jul2016, the clinical signs continued and the canine was examined by veterinarian at an emergency clinic. The canine exhibited eye redness and was administered oxygen therapy. Radiographs were performed and results are unknown. The canine was hospitalized and treatments are unknown. 09Jul2016, the dog was released from the hospital. 10Jul2016, the dog died. No necropsy was performed. No more information is expected. The case is closed. Follow-up received on 3rd Aug, 2016: On 29 Jun2016, a 7 year old, 21 pound, female, Pug canine, of unknown reproductive status, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around her neck by the owner. Approximately 3 hours post product application, the canine became lethargic and vomited once. On 30Jun2016, the canine developed periorbital edema, tachypnea, and vomited approximately 2 times. The vomiting resolved within approximately 15 minutes. On 03 July 2016, the signs continued and the collar was removed by the owner. The lethargy improved. On 07Jul2016, the clinical signs continued and the eyes were red and had discharge. The canine was examined by veterinarian at an emergency clinic. On exam, the left eye was cloudy and had conjunctivitis. The dog was tachypneic and short of breath. The dog experienced weight loss and was 17.6 pounds. Radiographs were performed and results are unknown. The patient was hospitalized and placed in an oxygen cage and administered 0.7 ml ceftiofur sodium intramuscularly, 1.0 ml of an unknown medication subcutaneously, 0.5 ml of dexamethasone by injection, 0.34 ml diphenhydramine by injection, an unknown amount of carprofen subcutaneously, and an unknown eye ointment placed oticly. On 08 Jul 2016, the signs continued and the canine remained in an oxygen cage. The canine was administered 0.7 ml ceftiofur sodium intramuscularly, 1 mL penicillin subcutaneously, and an unknown eye ointment placed oticly. On 09 Jul 2016, the signs continued and the canine remained in an oxygen cage. It was administered 0.7 ml ceftiofur sodium intramuscularly, 1 ml penicillin subcutaneously, and an unknown medication by an unknown route. The canine was discharged from the hospital and started on a regimen of prednisone 5 mg twice daily orally, Baytril (enrofloxacin) 68 mg 1 tab orally daily, and tramadol 50 mg on half tab twice orally daily by the owner. Bayer became aware of the involvement of Baytril on the last follow-up on 03 Aug 2016. On 10Jul2016, the dog died. No necropsy was performed. No more information is expected. The 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

Off-label use (dose too low). Lethargy is unspecific and may have numerous other causes, however may appear shortly after product application. The collar was removed after 3 days of wearing. After collar removal, dog showed eye disorders, respiratory disorders, weight loss, and vomiting. All these signs are not expected with appropriate topical product administration and as they appeared after collar removal, other unrelated causes are more likely. Signs went on and the dog was hospitalized but released from hospital approx. 2 weeks after collar removal. The dog died one day after release from hospital. Time between collar removal and death was 2 weeks which is a too long timeframe and thus product relation can be excluded. Death is not expected with product use and of course not after 2 weeks of collar removal. Oral exposure to the collar is not expected to cause serious sign either. 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 signs. Even though some information is not available (health status, necropsy report), considering serious chronology and early removal of the collar, a product relation is considered as unlikely.