New incident report
Incident Report Number: 2016-4287
Registrant Reference Number: 2016KP166
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 - Dog
Other (specify)
collarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Unknown
Other
Dog / Chien
Unknown
1
Unknown
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 died. It is unknown if a necropsy was performed. Due to the sensitive nature of the communication, limited information was obtained. Further attempts to gather additional information will not be made. The reporting party contacted Bayer Animal Health to inquire about a replacement collar and not to report the death of the patient. No further information expected.
Death
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. Further, reporting party does not believe product involvement as they contacted Bayer Animal Health to inquire about a replacement collar and not to report the death of the patient. Even though some information is not available (animal details, medical history, necropsy report and time to onset), sufficient information exists to rule out product relation completely. Overall, a product relation considered as unlikely.