Nouvelle déclaration d'incident
No de la demande: 2017-4032
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0012433
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
Incident chez un animal domestique
Pays: UNITED STATES
État: TENNESSEE
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: Seresto Collar unknown
Autre (préciser)
CollarOui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Professionnel de la santé
Dog / Chien
Shih Tzu
1
Femme
10
8.528
kg
Cutanée
>24 hrs <=3 days / >24 h <=3 jours
>24 hrs <=3 days / >24 h <=3 jours
Système
>24 hrs <=3 days / >24 h <=3 jours
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date in 2017, a 10 year old, 18.8 pound, neutered, female, Shih Tzu canine, in unknown condition, with concomitant medical conditions of elevated liver enzymes, and dermal mass on right flank, with history of mast cell sarcoma, had one Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 27-Mar-2017, the dog was examined by a veterinarian. The dog was vaccinated with unspecified vaccines and unknown bloodwork was performed. The dog continued to have elevated liver enzymes. On 31-Mar-2017, the dog exhibited dyspnea. The owner bathed the dog with an unspecified shampoo and the collar was removed. On 01-Apr-2017, the dog exhibited anorexia, adipsia, not defecating, and ataxia. No medical intervention was sought . On 02-Apr-2017, the dog died and no necropsy was performed. No more information is expected. Case is closed. Follow up received on 5th Apr 2017: On 27-Mar-2017, a 10 year old, 18.8 pound, neutered, female, Shih Tzu canine, in unknown condition, with concomitant medical conditions of elevated liver enzymes, and dermal mass on right flank, with history of mast cell sarcoma, had a routine examination by the veterinarian, vaccinated with unspecified vaccines and unknown bloodwork was performed;the concomitant elevated liver enzymes continued. On 28Mar2017, the dog had one Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 31-Mar-2017, the dog exhibited dyspnea. The owner bathed the dog with an unspecified shampoo and the collar was removed. On 01-Apr-2017, the dog exhibited anorexia, adipsia, not defecating, ataxia and collapsed after a walk. No medical intervention was sought. On 02-Apr-2017, the dog died and no necropsy was performed. No more information is expected. Case is closed.
Mort
O - Unclassifiable/unassessable Reported signs dyspnoea, anorexia and adipsia are unspecific signs and may have various other causes. Not defecating is not expected after product application, in this case it may be associated with anorexia. Ataxia and collapse are not anticipated with appropriate topical product administration. No oral product exposure reported. 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 serious signs 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Animal involved in this case was geriatric and had concomitant condition of elevated liver enzymes, dermal mass on right flank, with history of mast cell sarcoma which likely have contributed to reported signs and outcome. Even though time to onset is consistent, most of the signs were observed after collar removal. Although a relation to the product is deemed unlikely taking the animal's underlying medical problems and the product's safety profile into account, considering that the final cause for death remains unknown, the case is considered as unassessable.