New incident report
Incident Report Number: 2020-2836
Registrant Reference Number: USA-BAYERBAH-2020-US0030862 (Report 646842)
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: NORTH CAROLINA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto collar (unspecified)
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: K9advantixII pipette size unknown
Other (specify)
COLLAR, spot-onYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Australian Shepherd Dog
1
Unknown
7
Unknown
Skin
>1 yr / > 1 an
<=30 min / <=30 min
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Immediately post application, the dog exhibited rolling and whimpering. One day post application, in 2011, the rolling and whimpering resolved. On an unspecified date post application, in 2011, the dog was examined by a veterinarian and diagnosed with unspecified neoplasia. On an unspecified date post application in 2018 the neoplasia worsened and the dog died. No necropsy was performed. No more information is expected and this case is closed.
Death
Advantix Plus: O - Unclassifiable/unassessable Reported behavioural disorders are unspecific, however, may be a behavioural response to the feeling caused by the applied product. Time to onset is short. Later diagnosed unspecified neoplasia after product application is not expected. The active ingredients are not listed as mutagenic or carcinogenic. Other causes should be considered. Death after product application is not expected in dogs, as it is inconsistent with the pharmaco-toxicological profile of the product. Death in this case likely associated with underlying poor condition due worsening of neoplasia in geriatric status of the dog. No necropsy was performed. Though time to onset is short for initial signs, it is long for other reported signs. Considering overall aspects, a product connection is unassessable. Seresto: N - Unlikely Reported rolling, whimpering and neoplasia were reported prior to product use, ruling out product relation. Worsening of unspecified neoplasia followed by death is 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 in this case the result of pre-existing neoplasia combined with dog's age. A product connection is considered unlikely.