Nouvelle déclaration d'incident
No de la demande: 2015-3903
Numéro de référence du titulaire d'homologation: 2015CK272
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 2920 Matheson Boulevard
Ville: Missisaugua
État: ON
Pays: Canada
Code postal /Zip: L4W 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. 1556-155
Nom du produit: Seresto Collar - large dog
Autre (préciser)
CollarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Dog / Chien
boxer
1
Femme
8
63.9
lbs
Cutanée
>15 min <=2 hrs / >15 min <=2 h
>8 hrs <=24 hrs / > 8 h < = 24 h
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 26-Nov-2012 the dog began presenting abnormal behavior of "acting funny".On 28-Nov-2012 the dog had a seizure and death occurred. A necropsy is pending. The dog was not examined or treated by a veterinarian.Follow-up, 20 Dec 2012: On 05-Dec-2012 the necropsy showed several foreign in bodies in the dogs stomach and intestine. The abdominal cavity was full of fluid from peritonitis resulting in the death of the dog. It was also discovered that the dog had adenocarcinoma of the intestine along with chondroid and osseous metaplasia.18 Feb 2013: Technical assessment: The complained batch was manufactured and released according to specification. No deviations occurred which lead to the complained AE.
Mort
The product is not anticipated to cause seizures or death after appropriate topical product administration, as inconsistent with pharmaco-toxicological product profile. No oral product exposure reported. No neurological signs are expected without oral product uptake. Any action or treatment may trigger seizures in an animal with a respective disposition. Death possibly related to the seizure or other underlying medical condition. Time to onset though close, not indicative for product relation. Necropsy revealed several foreign bodies in stomach and intestine, and peritonitis and adenocarcinoma resulting in the dogs death. Considering this cause for the fatal outcome, product involvement was ruled out for this event.Technical evaluation of used batch did not reveal a connection between product and observed signs from a QA/technical perspective.