New incident report
Incident Report Number: 2016-4232
Registrant Reference Number: 2016KP136
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
Female
7
10
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>6 mos / > 6 mois
System
>1 wk <=1 mo / > 1 sem < = 1 mois
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date Mar2014, the cat developed abdominal swelling. On approximately 17Mar2014, the cat was examined by a veterinarian and diagnosed with an abdominal tumor via ultrasound. 12Apr2014, the cat was anesthetized with an unknown anesthetic agent and a surgical procedure was performed to debulk the abdominal tumor. The tumor could not be entirely removed. On 20Apr2014, the cat died and the collar was removed. It is unknown if a necropsy was performed.The collar was used off label as it was worn for longer than 8 months. No further information is expected. This case is closed.
Death
Reported abdominal swelling is not expected with topical collar application. No oral exposure was reported. It is likely associated with later diagnosed abdominal tumor via ultrasound. Abdominal tumor is not expected after appropriate topical product application. Further, 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 death 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. Death likely related to tumor associated conditions. Considering the known product profile and exceptionally long time to onset (more than 1 year), sufficient information exists to conclude that the product did not cause the event and product involvement was unlikely.