New incident report
Incident Report Number: 2021-3604
Registrant Reference Number: USA-BAYERBAH-2021-US0025884 (Report 707807)
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: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar Small
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Yorkshire Terrier
1
Female
13
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date post application, in approximately 2021, the dog exhibited breast cancer and died. No necropsy was performed.
Death
O - Unclassifiable/unassessable The reported serious signs such as breast cancer and death are not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause such 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. 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. Death may be consequence of reported breast cancer. Besides, the intent of the call was to inquire about product use in general and not to report this event. Considering some information missing (weight, health status, time to onset and no necropsy was performed), product involvement is not likely, however due to limited information case is considered unassessable.