New incident report
Incident Report Number: 2021-2628
Registrant Reference Number: USA-BAYERBAH-2021-US0017160 (Report 697938)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Domestic Animal
Country: UNITED STATES
Prov / State: NEW JERSEY
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto collar unnown
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 approximately 2021, the canine died. No known necropsy was performed. No further information is expected. This case is closed. Note: The intent of the call was to inquire about product use in general and not to report this event. This case is closed.
Death
O - Unclassifiable/unassessable Information was collected during an inquiry of a customer where information regarding the product, e.g., use of product, mode of action of product, was requested. Clinical information of death was mentioned in this call but were not considered to be product related, neither by customer nor by the MAH. Reported 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 sign 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Considering the product profile, product involvement is deemed unlikely, however due to limited information (animal details, time to onset and necropsy report), case is considered unassessable.