New incident report
Incident Report Number: 2016-4224
Registrant Reference Number: 2016KP128
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. 11556-155
Product Name: Seresto Collar - Dog
Other (specify)
collarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Labrador Retriever
1
Female
14
60
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>3 days <=1 wk / >3 jours <=1 sem
System
>1 wk <=1 mo / > 1 sem < = 1 mois
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Approximately 1 week post application, in 2015, the dog was anorexic, vomiting and lethargic. The owner removed the collar. Approximately 17 days post application, in 2015, the dog recovered without medical intervention. On an unspecified date in 2015, the dog died. No known necropsy was preformed. 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 the reaction to the Seresto collar, and not to report the death of the patient. No more information is expected. This case is closed.
Death
Vomiting is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). No oral product exposure occurred. Lethargy and anorexia may be consequence of vomiting. 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. Animal reported in this case was geriatric (14 years) which may be the likely cause for the death of an animal. Moreover, reason for the initial call was to discuss the reaction to the Seresto collar, and not to report the death of the patient. Time to onset is quite long. Death occurred after collar removal. Overall, considering all aspects a product relation is unlikely.