New incident report
Incident Report Number: 2020-5437
Registrant Reference Number: USA-BAYERBAH-2020-US0045215 (Report 662725)
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: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto collar unknown
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Unknown
1
Female
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in Feb2020, the dog was examined by a veterinarian and diagnosed with immune mediated hemalytic anemia. On an unknown date in Feb2020, the dog had an application site rash. On an unknown date in Feb 2020, the dog died. It is unknown if a necropsy was performed.
Death
O - Unclassifiable/unassessable Diagnosed immune mediated haemolytic anaemia is not expected following appropriate topical product application as inconsistent with product真真真s pharmacological profile. Time to onset is unknown. Other unrelated causes are more probable. The reported application site rash may occur in sensitive animals after product application. It is usually mild and transient. Onset time is unknown. Later reported, serious outcome of death is not expected following appropriate topical product application 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真真真 period and in 10 week old kittens and 7 week old puppies for a 6 months真真真 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. Death in the dog is most likely the consequence of immune mediated haemolytic anaemia. Overall, considering unknown time to onset and limited information about medical history, health status, animal details and necropsy report of animal, a product involvement is unassessable.