New incident report
Incident Report Number: 2018-2058
Registrant Reference Number: USA-BAYERBAH-2018-US0013558 (Report 479183)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississauga
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
Domestic Animal
Country: UNITED STATES
Prov / State: OHIO
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
Beagle
1
Unknown
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Persisted until death
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date post application, in approximately Apr2017, the canine died. No necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial communication was to discuss use of the product and not to report the death in this event. No more information is expected. The case is closed.
Death
N - Unlikely - 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Moreover, the reason for the initial communication was to discuss use of the product and not to report the death in this event. In case of suspected product involvement adverse event would have been reported in close proximity and not long time after (almost after 1 year). 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 is unlikely.