New incident report
Incident Report Number: 2018-0463
Registrant Reference Number: USA-BAYERBAH-2017-US0077960 (Report 463965)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
Domestic Animal
Country: UNITED STATES
Prov / State: OREGON
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Dog (unspecified)
Other (specify)
COLLARYes
Other Units: Collar
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Terrier (Rat)
1
Male
15
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 15-Feb-2017, 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 to Bayer Animal Health was to discuss the use of Seresto on a new puppy and not to report the death of the dog No further information is expected. This case is closed.
Death
N - Unlikely 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 animal is geriatric which should be considered in this case. In case of suspected product involvement adverse event could have been reported in close proximity and long time after (more than 10 months). Moreover, the reason for the initial call was to discuss the use of Seresto on a new puppy and not to report the death of the dog. Even though some information is not available (e.g. time to onset, necropsy report etc.) sufficient information exists to rule out product relation completely. Overall, a product relation considered as unlikely.