New incident report
Incident Report Number: 2018-3614
Registrant Reference Number: USA-BAYERBAH-2018-US0038902 (Report 505099)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
Domestic Animal
Country: UNITED STATES
Prov / State: PENNSYLVANIA
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
Animal's Owner
Dog / Chien
Crossbred
1
Male
Unknown
Unknown
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 01-Oct-2017, the dog died. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the phone call was to ask a question about a different pet, not to report the death in this event. No further information is expected. This case is closed.
Death
N - Unlikely 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. Furthermore, in case of suspected involvement sign would have been reported in close proximity and not a long time. Time to onset is long. Other causes are more probable. Moreover, the reason for the phone call was to inquire about a different pet, not to report the death in this event. Even though some information is not available (e.g. necropsy report), considering product's known safety profile, product relation considered unlikely.