New incident report
Incident Report Number: 2018-3617
Registrant Reference Number: USA-BAYERBAH-2018-US0039009 (Report 505137)
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: PENNSYLVANIA
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
Male
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 unspecified date in approximately 2017, the dog died. Due to the sensitive nature of the communication, specific relevant details were not obtained, nor will they be sought. No Necropsy was performed. The intent of the call was not to report death but to inquire about product use on another dog. This case is closed. 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. In case of suspected product involvement adverse event would have been reported in close proximity and not long time after. Moreover, the intent of the call was to inquire about product use on another dog and not report the death of this dog. Even though some information is not available (e.g. time to onset, necropsy report), considering unexpected serious outcome and intent of the call, a product relation is unlikely.