New incident report
Incident Report Number: 2019-3588
Registrant Reference Number: USA-BAYERBAH-2019-US0030411 (Report 572231)
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 Dog (unspecified)
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
unknown
1
Unknown
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in approximately 2018, post placement, the dog died due to an unspecified neoplasia. It is unknown if medical treatment was sought or provided. No necropsy was performed. No further information is expected. This case is closed. The intent of the call was to inquire about product use in general and not to report this event.
Death
O - Unclassifiable/unassessable The reported neoplasia and death are not expected following appropriate topical product application as inconsistent with product's 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. In this case animal may have died due to unspecified neoplasia. Moreover, the intent of the call was to inquire about product use in general and not to report this event. Overall, considering low level of information (e.g. time to onset, necropsy report and health status), a product relation remains unassessable.