New incident report
Incident Report Number: 2017-6929
Registrant Reference Number: USA-BAYERBAH-2017-US0058583 (Report 444800)
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: NORTH CAROLINA
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
German Boxer
1
Unknown
Unknown
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in approximately Jul-2017, the dog 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 phone call was to discuss product use on another pet in the home and not to report the death in this event
Death
N-Unlikely: Death is 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Moreover owner does not believe in product connection as the reason for the initial phone call was to discuss product use on another pet in the home and not to report the death in this event. Even though low level of information is provided (as unknown time to onset), considering the known product profile, sufficient information exists to conclude that the product did not cause the event and product involvement remains unlikely. The reason for the initial phone call was to discuss product use on another pet in the home and not to report the death in this event.