New incident report
Incident Report Number: 2017-0587
Registrant Reference Number: 2017KP089
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 - Large Dog
Other (specify)
collarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Unknown
1
Female
Unknown
Unknown
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 unknown date post application in 2016, the dog was examined by a veterinarian and was diagnosed with a brain tumor. Approximately 2 weeks post diagnosis, on an unknown date in 2016, the dog died. It is unknown if a 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 phone call was to discuss the use of the product and not to report the death of the patient. No more information is expected and this case is closed.
Death
Development of brain tumor is not expected with topical product application and is not in line with the pharmacotoxicological product profile. Death is also 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Fatal outcome likely consequence of diagnosed brain tumor and thus, sufficient information exists to rule out product involvement. Moreover, the reporting party contacted Bayer Animal Health to inquire about product use and not to report the death of this animal. Finally, even though some information (e.g. animal details, time to onset, health status and necropsy results) is not available, considering known product safety profile a product relation is unlikely.