New incident report
Incident Report Number: 2017-2207
Registrant Reference Number: 2017KP151
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 Collar - Cat
Other (specify)
collarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Other
Cat / Chat
Domestic Shorthair
1
Male
3
7
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date post application, in approximately July 2016, the cat exhibited application site pruritus; the cat was not seen by a veterinarian and the clinical sign continued. Follow up received on 6 Jan 2016: On an unspecified date, in approximately Dec 2016, the cat died of unknown causes; no necropsy was performed. No more information is expected. Case is closed.
Death
Reported application site pruritus may occur in sensitive animals after product application. It is usually mild and transient. However, later reported unexplained death is not expected following appropriate topical product application as inconsistent with products 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. Time to onset is consistent for application site disorder however is exceptionally long for later reported serious sign. Cause of death is unknown and necropsy was not performed. When considering the known product profile, a product relation seems unlikely, however due to limited information, case cannot be assessed. Finally, product involvement is considered unassessable.