New incident report
Incident Report Number: 2018-1234
Registrant Reference Number: USA-BAYERBAH-2018-US0003933 (Report 469991)
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: NEW YORK
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: K9 AdvantixII pipette size unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: Seresto Dog unspecified
Other (specify)
Spot-on and CollarYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Beagle
1
Female
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in 2016, the canine had generalized pruritus. On an unknown date in 2016, the canine died. It is unknown if a necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. No further information is expected. Case is closed.
Death
Advantix: N-Unlikely: Pruritus is not expected to be generalised but rather be linked to the application site. Death not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Very low level of information (age, medical history and time to onset unknown - necropsy not available) as the intent of the phone call to discuss the use of the product and not to report the death of the patient. No signs of allergy/anaphylactic reaction reported. Even though time to onset unknown, occurrence of sign within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity and not long time after (approximately 2 years). Other etiologies more probable. Considering all aspects, product connection deemed to be unlikely. Seresto: N-Unlikely: Pruritus on other than the application site is not typically seen with topical product administration. Other causes (e.g. allergies) have to be considered as well. Initial pruritus may represent a reaction to the collar in a sensitive animal. 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. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (approximately 2 years). Moreover, the owner does not seem to believe in product relation as the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Though time to onset is unknown, considering known product safety profile and intent of the call, a product relation is considered unlikely.