Nouvelle déclaration d'incident
No de la demande: 2015-3872
Numéro de référence du titulaire d'homologation: 2015TH284
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 2920 Matheson Blvd
Ville: Mississauga
État: ON
Pays: Canada
Code postal /Zip: L9W 5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: UNKNOWN
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar - large dog
Autre (préciser)
CollarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Dog / Chien
Collie
1
Homme
10
60
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
Système
Persisted until death
Oui
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 01-Aug-2012, a 10 year old, 60 pound, neutered, male, Collie canine, in poor condition, with hind limb ataxia, arthritis, urinary retention, scarring of the prostrate, possible bladder stones and a history of a herniated cervical disk, was administered 1 tube of Advantage Multi for Dogs (10% imidacloprid + 2.5% moxidectin) Topical Solution Unknown once topically by the owner. On approximately 01Apr2013, the owner placed one Seresto Large dog collar (flumethrin-imidacloprid) around the neck. The collar was removed on approximately 22Apr2013. On 27Aug2013 the dog presented to the veterinarian with a fever of 104 degrees and was diagnosed with a bladder infection. The veterinarian prescribed Baytril 136mg taste tab (enrofloxacin) three tablets to be given once daily for ten days. On 28Aug2013 the dog was much improved and the fever had resolved. On 29Aug2013, on day three of the administration of Baytril 136 taste tabs, the dog became adipsic, inappetant, ataxic, lethargic and became unable to urinate. The owner continued the daily administration of the product. On 03Sep2013 the dog developed a painful abdomen which resolved approximately two hours later. On 05Sep2013 the last dosing of the Baytril 136 was complete.On 12Sep2013 the dog developed intermittent diarrhea. On approximately 13Sep2013 the dog presented to the veterinarian and was administered an unknown amount of intravenous fluids and the veterinarian performed low level laser therapy. The veterinarian also instructed the owner how to express the dog's bladder. On 29Sep2013 the dog developed a painful abdomen. The owner administered an unknown amount of tramadol and gabapentin without the veterinarians knowledge. On 01Oct2013 the developed a cough that was productive. Approximately twelve hours later the dog died.
Mort
N- Unlikely Reported signs including death are unexpected, as inconsistent with pharmaco-toxicological product profile. Dog was rather old, in a poor condition and had a known history of a variety of pre-existing diseases, in particular urinary tract disorders, which most likely have been the underlying causes in this case. Collar was worn without signs for 3 weeks. Reported signs started 4 months after collar removal which is a too long onset time to be product related. Finally, a product connection can be excluded.