New incident report
Incident Report Number: 2019-3122
Registrant Reference Number: USA-BAYERBAH-2019-US0021435 (Report 562889)
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
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Dog Collar (unspecified) (Flumethrin-Imidacloprid)
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
German Shepherd Dog
1
Female
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in 2017 post collar placement, the dog developed generalized pruritus and the collar was removed. Approximately 1 week post collar removal, the generalized pruritus resolved. On an unspecified date in 2018, the dog died. It is unknown if a necropsy was performed. No further information is expected. This case is closed.
Death
O - Unclassifiable/unassessable Pruritus on other than the application site is not typically seen with topical product administration. Other causes (e.g. allergies) must be considered although not described. Time to onset is unknown. Later reported 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. Moreover, death was reported post collar removal, in unknown time. No necropsy was performed. State of health and age of animal is unknown in this case. Considering all aspects, a product relation is unassessable.