Nouvelle déclaration d'incident
No de la demande: 2019-0799
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0000433 (Report 541476)
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer inc
Adresse: 2920 Matheson BLVD
Ville: Mississaugua
État: ON
Pays: Canada
Code postal /Zip: L5W5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: MICHIGAN
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar Unknown
Autre (préciser)
COLLAROui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Labrador Retriever
1
Homme
5
Inconnu
Cutanée
>6 mos <=1 yr / > 6 mois < = 1 an
>6 mos / > 6 mois
Système
Persisted until death
Oui
Oui
4
Day(s) / Jour(s)
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unknown date in Nov-2018, after approximately 8 months of use, the collar was removed. On approximately 28-Dec-2018, the canine became anorexic. The canine was examined by a veterinarian and bloodwork was performed. The canine was diagnosed with acute kidney failure and Lyme disease. The canine was hospitalized on dialysis. On 29-Dec-2018, the canine was transferred to a university clinic, continued on dialysis, and had a blood transfusion. On 01-Jan-2019, the canine died and a necropsy was performed; the results were unknown. No further information is expected. Case is closed.
Mort
N - Unlikely Acute renal failure is neither expected nor inline with products pharmaco-toxicological product profile. However sign may be consequence of diagnosed lyme disease. In this case, no ticks seen on the dog. In case of attachment, ticks will be killed and fall off the host within 24 to 48 hours after infestation without having had a blood meal, as a rule. However, attachment of single ticks and even sucking of blood and thus transfer of tick borne diseases such as diagnosed lyme disease cannot be excluded while the collar is worn and simply reflects the labeled claim of efficacy that is not 100% against ticks especially when infestation pressure is high. Thus, infection with tick borne diseases despite wearing a collar can occur exceptionally and is consistent with the product's claimed efficacy. This issue is addressed in the product information. Reported anorexia is an unspecific sign and likely associated with earlier described signs. Death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. Product has wide margin of safety. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Moreover all signs were reported after collar removal. Animal likely died due to acute renal failure. Time to onset is long. Considering all aspects, product relation is unlikely.