New incident report
Incident Report Number: 2015-3799
Registrant Reference Number: 2015KP202
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 Matheson Boulevard
City: Missisaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Domestic Animal
Country: UNITED STATES
Prov / State: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar - Large Dog
Other (specify)
CollarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Unknown
Other
Dog / Chien
Unknown
1
Male
Unknown
Unknown
Skin
>8 hrs <= 24 hrs / >8 h <= 24 h
>8 hrs <=24 hrs / > 8 h < = 24 h
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
The dog died the next day. It is unknown if a necropsy was performed. No further information is expected. This case is closed. The reporting party originally called Bayer Animal Health to determine if the collar could be stored for a period of time before being used again not to report the death of the dog.
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 death 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. The dog was reported to have a pre-existing condition of liver tumor, which was rather the reason of death. Unknown if necropsy was performed. Time to onset short (1 day), though, but no information provided that suggested a relation to the applied collar.. The reporting party originally called Bayer Animal Health to determine if the collar could be stored for a period of time before being used again and thus, the reporter did not assume product involvement on outcome. Considering the provided data, sufficient information exists to confirm that the product did not cause the event and product involvement was considered unlikely.