Nouvelle déclaration d'incident
No de la demande: 2019-4442
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0036868 (Report 579101)
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: UNKNOWN
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Large Dog
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-141
Nom du produit: K9 Advantix II pipette size unknown
Autre (préciser)
COLLAR ; Spot-onOui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Crossbred [Chihuahua x Terrier (Jack Russell)]
1
Inconnu
4
9.07
kg
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Unknown / Inconnu
Oui
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 02 Jul 2019, the canine exhibited unspecified urinary signs, including frequent squatting with lack of urine production. In addition, the dog was not eating or drinking, was ataxic in the back end and exhibited weight loss. The canine was examined by a veterinarian and weighed 18.2 pounds. A urinalysis was performed and was within normal limits. The dog was started on amoxicillin/ clavulanic acid. On 03 Jul 2019, the collar was removed and the dog was bathed with dish soap. On 05-Jul-2019, the canine weighed 15 pounds. On 08 Jul 2019, the dog was examined by a veterinarian. The clinical signs continued. A complete blood count was performed and was within normal limits. Radiographs were performed and the results are unknown. On 10 Jul 2019, the dog was examined by a veterinarian and exhibited ventral neck flexion, but no other clinical signs. No diagnostics were performed. Approximately 8 hours later, the dog exhibited meningitis, drooping, left facial nerve paralysis, seizure, drooling, nystagmus, muscle contractions of the face, head pressing, hallucinating, abnormal behavior, loss of hearing, loss of sight, rigid jaw. The dog died and no necropsy was performed.
Mort
Seresto: N - Unlikely A tick was reported prior to collar application, hence not related to the product. Renal disorders are not expected following appropriate topical product application. However animal had concomitant history of urinary tract infection, which may have contributed to the signs. Further, ataxia is not typically seen with appropriate topical product administration. Not eating and drinking is likely associated with other signs. Weight loss is not expected either. The collar was removed, and despite this, dog's condition deteriorated. Further reported serious neurological, sensory and behavioural signs are not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Overdose of 5 collars around the neck of adult dogs for an 8 months period and in 7 week old puppies 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. Signs are likely associated with reported meningitis, which typically has an infectious cause. Moreover, signs reported after collar removal. Death is likely the result of the meningitis. Time to onset is long. Overall, a product relation is unlikely. Advantix: N - Unlikely Dog was treated with the product in 2018. A single tick was reported in 2018, unknown how long after product application. The product's repellent effect against ticks is not 100%. Attachment of individual ticks is possible when infestation pressure is high. This is mentioned in the product information. Moreover, without further information, it is possible that the tick was found after the product's efficacy period of 4 weeks. Later reported signs were reported long time after product use (at least 7 months). Signs are not expected following product use, as it is inconsistent with the pharmaco-toxicological profile of the product. In fact, meningitis was diagnosed, which commonly has an infectious cause. Considering overall aspects, a product connection is considered unlikely.