New incident report
Incident Report Number: 2018-1603
Registrant Reference Number: USA-BAYERBAH-2018-US0006781 (Report 473126)
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: ALABAMA
Unknown
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
Unknown
1
Unknown
Unknown
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 an unknown date post application, in approximately 2015, the dog died due to unknown circumstances. No known 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 Seresto on the current pet and not to report the death of the patient. No further information is expected. This case is closed. Note: previouis exposure is well tolerated.
Death
N-unlikely: Reported death is not expected following appropriate topical product application as inconsistent with product's 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. Previous exposure was well tolerated. Additionally, reason for initial call was to discuss the use of the product and not to report the death of the patient. In case suspected product involvement adverse event would have been reported in close proximity of the death of the animal not long time after (more than 2 years). Even though some information is missing (e.g. animal details, time to onset and necropsy report), sufficient information exists to rule out product relation completely. Overall, a product involvement is deemed to be unlikely.