Nouvelle déclaration d'incident
No de la demande: 2019-1875
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0007403 (Report 549796)
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: OHIO
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto collar Small
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Professionnel de la santé
Cat / Chat
Domestic Shorthair
1
Femme
13
5.761
kg
Cutanée
>8 hrs <= 24 hrs / >8 h <= 24 h
>8 hrs <=24 hrs / > 8 h < = 24 h
Système
Persisted until death
Oui
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 07Mar2019, the cat refused to eat in the morning (inappetent) and the owner removed the collar. At approximately 3 pm in the afternoon, the cat became limp and began vocalizing. At approximately 4pm the cat presented to the veterinarian. Upon examination, the cat was weak, vocalizing, had a temperature of 98 (hypothermic), and began to seizure. The seizure resolved after approximately 30 seconds, but the cat continued to have focal facial fasciculation. The cat was placed on oxygen. The cat then went into cardiac arrest. Cardio- pulmonary resuscitation was initiated and the cat was administered intracardiac injections of epinephrine and atropine. Cardio-pulmonary resuscitation was unsuccessful and the cat was pronounced dead. No necropsy was performed. The veterinarian suspects that the collar was counterfeit. MAH comment: This collar is suspected to be a counterfeit.
Mort
O - Unclassifiable/unassessable This collar is suspected counterfeit product. Nevertheless, even with the genuine collar, the reported signs of innapetance, weakness, vocalization and hypothermia are not expected and may have numerous other causes. Those signs are rather a manifestation of neurological signs reported: limpness, fasciculation, seizures and following sign of cardiac arrest. However, such signs, including serious signs of seizures, cardiac arrest and death are not expected following appropriate product use. The product is not anticipated to cause any serious neurological disorders such as seizures or death after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. Overdose of 5 collars around the neck of adult cats for an 8 months period and in 10 week old kittens for a 6 months period did not cause serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Even with oral product exposure, seizures are not seen. Merely gastrointestinal signs may occur. Any action or treatment may trigger seizures in an animal with a respective disposition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Time to onset short though. Considering the product profile, product involvement is deemed unlikely, however due to limited information and reported suspected counterfeit the case is considered unassessable.