New incident report
Incident Report Number: 2016-2760
Registrant Reference Number: 2016KP078
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 - unknown
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 unspecified date in Oct 2014 the dog died. No necropsy was performed. No more information is expected. Case is closed. Follow up received on 21 Mar 2016: On an unspecified date in Feb-2014 a canine of unknown signalment and condition with a concomitant osteosarcoma, had 1 Seresto (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. Note: The intent of this case was not to report this event but to inquire on the Seresto product. Case is closed.
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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Further, the time to onset is exceptionally long (approximately 8 months). Most likely the dog died due to the underlying osteosarcoma. Moreover, in case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. Rather, the intent of the primary call was not to report this event but to inquire on the Seresto product. Considering all aspects, even though some information is missing (product and animal details) and no necropsy was performed, product relation is deemed to be unlikely.