New incident report
Incident Report Number: 2020-1293
Registrant Reference Number: USA-BAYERBAH-2020-US0009072 (Report 624510)
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. Unknown
Product Name: K9advantixII pipette size unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar unknown
Other (specify)
Spot-on and CollarYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Cockerpoo
1
Unknown
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in approximately 2019, the canine exhibited anorexia and other unspecified gastrointestinal signs. The canine was examined and unspecified biopsies were obtained. The canine was diagnosed with lymphangectagia and lymphoma. It was unknown if treatments were performed. The canine died. It was unknown if a necropsy examinations was performed. No further information is expected. This case is closed.
Death
Advantix Plus Spot-on pipette size unknown: N - Unlikely Reported anorexia is very unspecific and may have many other numerous causes. Reported gastrointestinal signs are not expected after product use. Further reported lymphangectagia, lymphoma and death after product application are not expected, as it is inconsistent with the pharmaco-toxicological profile of the product. In fact, the intent of the call was to inquire about product use in general and not to report this event. Other etiologies are likely. Long time to onset allows to exclude product relation. Considering overall aspects, a product connection is unlikely. Seresto Collar unknown: O - Unclassifiable/unassessable Reported anorexia and gastrointestinal signs are unspecific and may have other numerous causes. However, these signs in this case are likely associated with diagnosed lymphangectagia and lymphoma. Diagnosed lymphangectagia, lymphoma 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. Outcome was likely the consequence of diagnosed lymphangectagia and lymphoma. Considering limited information regarding time to onset and animal details are unknown, a product involvement is unassessable.