New incident report
Incident Report Number: 2020-5429
Registrant Reference Number: USA-BAYERBAH-2020-US0043087 (Report 660111)
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 150 Research Lane, Suite 120
City: Guelph
Prov / State: ON
Country: Canada
Postal Code: N1G 4T2
Domestic Animal
Country: UNITED STATES
Prov / State: KENTUCKY
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto collar large
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Retriever - Labrador crossbred dog
1
Female
4
26.762
kg
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
Unknown / Inconnu
System
Unknown / Inconnu
Yes
Yes
5
Day(s) / Jour(s)
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in Jun-2020, the dog developed stiffness. On approximately 10-Aug-2020, the stiffness worsened. On 12-Aug-2020, the dog developed anorexia and adipsia. On 13-Aug-2020, the dog was evaluated by a veterinarian and unspecified bloodwork performed revealed elevated BUN and creatinine, and was positive for Lyme disease and Ehrlichiosis. The dog was hospitalized on intravenous fluids and unspecified intravenous medications. On 17-Aug-2020, the intravenous catheter was removed and oral medications were started. The dog developed emesis. On 18-Aug-2020, the dog died. No necropsy was performed.
Death
O - Unclassifiable/unassessable Reported stiffness is not expected following appropriate topical product application as inconsistent with product真真真s pharmacological profile. Anorexia and adipsia are unspecific signs and may have other causes. Blood parameters such as elevated BUN and creatinine are not expected after product application. In this case signs likely associated with Lyme disease and Ehrlichiosis. Emesis is an unspecific sign and may have other causes. No oral exposure reported. Emesis may be a consequence of elevated renal values. Time to onset is long. Further reported death is not expected as inconsistent with product真真真s pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing 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. 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 (e.g. Lyme disease and Ehrlichiosis) cannot be excluded while the collar is worn and simply reflects the labelled 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真真真s claimed efficacy as addressed in the product information. In this case, no ticks reported. Considering limited information regarding health status and necropsy details, case is considered unassessable.