New incident report
Incident Report Number: 2018-2326
Registrant Reference Number: USA-BAYERBAH-2018-US0020138 (Report 484978)
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: FLORIDA
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
Unknown
1
Unknown
18
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 25-Dec-2017, the dog died. No known necropsy was performed. No further information is expected. This case is closed. Due to the sensitive nature of the communication, specific relevant details were not obtained, nor will such be sought. The reason for the initial call was to discuss product use on other pets in the home and not to report the death in this event. No further information is expected. This case is closed.
Death
N - Unlikely Reported 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 sign 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. The animal involved in this case was geriatric (18 years) and in unknown health condition. Moreover, the reason for the initial call was to discuss product use on other pets in the home and not to report the death in this event. Even though some information (e.g. time to onset and necropsy results) not available, considering known product profile, a product involvement is deemed to be unlikely.