New incident report
Incident Report Number: 2017-4009
Registrant Reference Number: USA-BAYERBAH-2017-US0018945
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: GEORGIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar Small cat
Other (specify)
collarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
Unknown
1
Female
12
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 2016, a 12 year old, female, Unknown Breed feline, of unknown weight, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On an unspecified date Dec-2016, the cat died. It is unknown if a 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 is expected and the case is closed.
Death
N - Unlikely Reported 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. Other potential causes are more probable in the geriatric animal. 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. In case suspected product involvement adverse event would have been reported in close proximity of the death of the animal not long time after (after 3 months). Even though some information is not available (e.g. animal details, health status, medical history and necropsy report), sufficient information exists to rule out product relation completely. Overall, a product involvement is deemed to be unlikely.