New incident report
Incident Report Number: 2017-4047
Registrant Reference Number: USA-BAYERBAH-2017-US0014832
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: ARKANSAS
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar Cats
Other (specify)
CollarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
Domestic Shorthair
1
Male
10
2.722
kg
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
>1 mo and <= 2mos / >1 mois et < = 2mois
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in 2015, a 10 year old, approximately 6 pound, neutered, male, Domestic Shorthair feline, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Cat Collar (Flumethrin-Imidacloprid) placed around the neck by the owner. Approximately 2 weeks post collar placement on an unspecified date in 2015, the cat developed weight loss and application site alopecia. Approximately 2 months post collar placement on an unspecified date in 2015, the cat was examined by a veterinarian; blood was collected for unspecified blood work that was performed and the cat was diagnosed with liver failure. The cat died and no necropsy was performed. The collar was removed. 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. This case is closed.
Death
N - Unlikely The reported application site alopecia may occur in sensitive animals after product application. It is usually mild and transient. Sign is consistent. Reported weight loss, subsequently diagnosed liver failure and 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. Product has wide margin of safety. Animal involved in this case was geriatric and likely died due to liver failure. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (approximately 2 years). 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. Time to onset is short for initial signs, but it is long for this serious outcome. Even though some information is not available (health status, medical history and necropsy result), considering the known product profile and serious outcome of the case, a product involvement is deemed to be unlikely.