Nouvelle déclaration d'incident
No de la demande: 2017-6534
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0036610
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: PENNSYLVANIA
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto collar small dog
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Dog / Chien
Yorkshire Terrier
1
Femme
1.66
1.814
kg
Cutanée
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 mo <=2 mos / > 1 mois < = 2 mois
Système
>1 wk <=1 mo / > 1 sem < = 1 mois
Oui
Oui
4
Day(s) / Jour(s)
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 15-Apr-2017, a 20 month old, 4 pound, neutered, female, Yorkshire Terrier canine, in unknown condition, with no known concomitant medical conditions, had one Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. The package insert that came with the collar was a different size, contained distorted graphics and did not have the Bayer trademark. On 29-May-2017 the dog exhibited anorexia. On 06-Jun-2017 the dog exhibited halitosis, and rubbing mouth on carpet(behavioral). The dog was seen by a veterinarian. Blood work was performed and the dog was diagnosed with kidney failure(BUN elevated beyond readable level). An in house ELISA test was performed and the dog was Lyme positive. A urinalysis was performed and revealed high protein (390). The dog was hospitalized and treated with sucralfate, intravenous fluids, intravenous hetastarch, maropitant citrate, pantoprazole and ampicillin. On 07-Jun-2017 the dog was treated with doxycycline, mycophenolate, metaclopramide, and vitamin B12. A quantitative C6 test was performed and was positive for Lyme (184). The dog exhibited abdominal pain. On 09-Jun-2017 the dog exhibited cardiac arrest and was treated with atropine, epinephrine, and dextrose. The dog died. No necropsy was performed.
Mort
N - Unlikely Reported anorexia and behavioural signs are unspecific and may have various other causes. Halitosis is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). No oral product exposure reported. Time to onset long for these signs. Further diagnosed renal disorders are neither expected nor inline with products pharmaco-toxicological profile. Further reported high protein upon urinalysis and abdominal pain are not expected after appropriate topical product application. Time to onset long as well. They likely associated with reported renal disorders. Lyme disease was diagnosed, however in this case, no ticks seen on dog. In case of attachment of ticks these 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 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 products claimed efficacy. This issue is addressed in the product information. Subsequent cardiac arrest and death are neither expected nor inline with products pharmaco-toxicological profile. Oral exposure to the collar is not expected to cause serious signs either. Product has wide margin of safety. Animal has probably died because of reported renal failure and cardiac arrest. Time to onset is long. Finally, considering all aspects, product relation is unlikely.