New incident report
Incident Report Number: 2017-4056
Registrant Reference Number: USA-BAYERBAH-2017-US0015890
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: MASSACHUSETTS
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar Unknown Size
Other (specify)
CollarYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
German Shepherd
1
Male
10
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in approximately 2016, a 10 year old, male, Shepherd - German dog, of unknown reproductive status and condition, with no known concomitant medical conditions, had 1 Seresto (unspecified) collar (Flumethrin-Imidacloprid) placed around the neck by the animal owner. On an unspecified date in Jan 2017, the dog was examined by a veterinarian who diagnosed congestive heart failure and the dog died. It is unknown if a necropsy was performed. No further information is expected. The case is closed. 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 call was to discuss product use on a new pet and not to report the death in this event.
Death
N - Unlikely The reported congestive heart failure and death are 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. Death was most likely as a consequence of heart failure. Dog involved in this case was geriatric as well. Moreover, the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Though time to onset is unknown, it seems long. Finally, even though some information is missing (necropsy, product details, medical history) sufficient information exists to rule out product relation completely. Finally, a product relation is considered as unlikely.