New incident report
Incident Report Number: 2018-2056
Registrant Reference Number: USA-BAYERBAH-2018-US0012955 (Report 478492)
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: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Cat
Other (specify)
COLLARYes
Other Units: Collar
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
Unknown
1
Male
6
7.711
kg
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 unknown date in Dec2016, post application, the feline died. No necropsy was performed and it is unknown if the feline was examined by a veterinarian. 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 this case is closed.
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. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (more than 1 year). Moreover, the reason for the initial communication was to discuss use of the product and not to report the death in this event. Even though some information is not available (e.g. time to onset, necropsy report are unknown), sufficient information exists to rule out product relation. Overall, a product relation is considered as unlikely.