New incident report
Incident Report Number: 2019-4458
Registrant Reference Number: USA-BAYERBAH-2019-US0041871 (Report 584399)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Domestic Animal
Country: UNITED STATES
Prov / State: UNKNOWN
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Large Dog
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Cavalier King Charles Spaniel
1
Male
8.5
15.87
kg
Skin
>8 hrs <= 24 hrs / >8 h <= 24 h
>8 hrs <=24 hrs / > 8 h < = 24 h
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 19-Jul-2019 the canine was ataxic and the collar was removed. On 21-Jul-2019 the canine died at home. No necropsy was performed. No further information is expected. This case is closed.
Death
O - Unclassifiable/unassessable Reported ataxia is not typically seen with appropriate topical product administration. Even with oral product exposure which was not reported only transient gastrointestinal signs are expected. Time to onset is rather indicative of a mere behavioural reaction to the collar than a true neurological condition. 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. 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Moreover, animal died after 2 days of collar removal. Other unrelated causes must be considered in this case. Considering the product profile, product involvement is deemed unlikely regarding death of the animal, however due to limited information (e.g. health status and medical history are unknown), case is considered unassessable.