New incident report
Incident Report Number: 2016-6700
Registrant Reference Number: 2016KP258
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
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
Australian Shepherd
1
Unknown
Unknown
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
>1 wk <=1 mo / > 1 sem < = 1 mois
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 08-Jul-2016, the reflectors fell off the collar (product defect). On approximately 31-Jul-2016, the dog was attacked by coyotes and died. The owner removed the collar. No known necropsy was performed. Due to the sensitive nature of the communication, limited information was obtained. Further attempts to gather additional information will not be made. The reporting party contacted Bayer Animal Health to inquire about a storage of the collar and not to report the death of this animal.
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 anaphylaxis reported which would have occurred in close proximity to the collar application. The dog was attacked by coyotes and died. Also owner does not believe in product connection as the intent of the reporting party was just to inquire about a storage of the collar and not to report the death of this animal. Finally, considering the known product profile and long time to onset even though no necropsy was performed sufficient information exists to conclude that the product did not cause the event and product involvement considered to be unlikely.