New incident report
Incident Report Number: 2016-6704
Registrant Reference Number: 2016KP262
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
Other (specify)
collarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Labrador Retriever
1
Female
13
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date post application, in 2014, the dog died. No 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 call was to discuss the use of our product on another animal, and not to report the death of the patient. No further information is expected this case is closed.
Death
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. No signs of allergy/anaphylaxis reported which would have occurred in close proximity to the collar application. Animal owner does not believe in product connection as the reason for initial call was to discuss the use of our product on another animal, and not to report the death of the patient. The animal involved in this case was geriatric. Though exact time to onset is unknown and no necropsy was performed, considering the known product profile, a product involvement was deemed to be unlikely.