New incident report
Incident Report Number: 2018-5475
Registrant Reference Number: USA-BAYERBAH-2018-US0045426 (Report 511130)
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: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar unknown
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 2018, the canine died. 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 phone call was to discuss the fleas on current animals and not to report the death in this event. No more inforamtion is expected. The 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. Other causes seem more probable. Furthermore the reason for the initial phone call was to discuss the fleas on current animals and not to report the death in this event. Even though some information is unavailable (time to onset and necropsy findings), considering product¿¿¿¿¿¿s safety profile and intent of the call, product involvement is unlikely.