New incident report
Incident Report Number: 2017-4037
Registrant Reference Number: USA-BAYERBAH-2017-US0013263
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
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. Unknown
Product Name: Seresto Dog Collar unknown
Other (specify)
CollarYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Golden Retriever
1
Unknown
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Other / Autre
specify Unknown
(eg. description of the frequency and severity of the symptoms
On an unknown date in 2016, a Retriever (Golden) canine, of unknown signalment, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Dog (unspecified)(Flumethrin-Imidacloprid) collar placed around the neck by the owner. On an unknown date post application in 2016, the canine was examined by a veterinarian and was diagnosed with an unspecified neoplasia. It was unknown if any treatments were performed. On an unknown date post application, in 2016, 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 phone call was to discuss the use of the product and not to report the death of the patient. No further information expected. This case is closed.
Death
N - Unlikely The reported serious sign such as unspecified neoplasia associated with death of the animal not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause such 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. Fatal outcome was likely consequence of unspecified neoplasia and thus, sufficient information exists to rule out product involvement. Moreover, the owner did not believe in product involvement either as the reason for initial call was to discuss the use of the product and not to report the death of the patient. Although no necropsy performed, a product involvement is considered unlikely.