New incident report
Incident Report Number: 2018-0917
Registrant Reference Number: USA-BAYERBAH-2018-US0000854 (Report 466579)
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: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Large Dog
Other (specify)
COLLARYes
Other Units: Collar
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Golden Retriever
1
Unknown
11
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
>2 mos and <=6mos />2 mois et <=6mois
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in approximately May-2017, the canine had liver disease and was started on an unspecified liver medication. On an unknown date in Aug-2017, the canine died and no necropsy was performed. No further information is expected. This case is closed. 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.
Death
N-Unlikely: Reported liver disease and death are not expected following appropriate topical product application as inconsistent with products 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 geriatric dog may have died due reported liver disease. Moreover, the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Even though some information is not available (e.g. animal details, necropsy report and time to onset), considering available information, a product relation is unlikely.