New incident report
Incident Report Number: 2018-2758
Registrant Reference Number: USA-BAYERBAH-2018-US0026680 (Report 492753)
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
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Small Dog
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 in 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 phone call was to ask if the deceased pets Seresto collar could be used on another pet, and not to report the death in this event. No further information is expected. This case is closed.
Death
N - Unlikely 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Even though some information is not provided (time to onset, circumstances of death and necropsy), considering the known product profile and intent of the reporter as to ask if the deceased pets Seresto collar could be used on another pet, and not to report the death in this event, sufficient information exists to conclude that the product did not cause the event and product involvement is considered unlikely.