New incident report
Incident Report Number: 2018-2279
Registrant Reference Number: USA-BAYERBAH-2018-US0023463 (Report 489155)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
Domestic Animal
Country: UNITED STATES
Prov / State: GEORGIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Dog collar (unspecified)
Other (specify)
COLLARYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
unknown
1
Unknown
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 unknown date in approximately 2017 the canine passed away. No necropsy was performed. No further information is expected. This case is closed. The intent of the call was to discuss product use in another pet and not to report the death of this canine.
Death
N - Unlikely 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Moreover, the reason for the initial phone call was to discuss if the product could be used on another pet and not to report the death in this event. In case suspected product involvement adverse event would have been reported in close proximity and long time after. Even though some information is not available (e.g. animal details, time to onset and necropsy report), sufficient information exists to rule out product relation completely. Overall, a product relation consider as unlikely.