New incident report
Incident Report Number: 2018-1623
Registrant Reference Number: USA-BAYERBAH-2018-US0009554 (Report 475389)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississauga
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
Animal's Owner
Dog / Chien
Miniature Schnauzer
1
Male
10
11.34
kg
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 post application in Aug2016, the canine died. No known 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 communication was to discuss the expiration date of the product and not to report the death in this event. No more information is expected and 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 dogs for an 8 months period without causing serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Dog involved in this case was geriatric with a concomitant medical condition of diabetes. Moreover, the reason for the initial phone call was to discuss expiration date of the product and not to report the death in this event. Even though some information is not available (e.g. time to onset, health status and necropsy report), considering known product profile a product relation is unlikely.