New incident report
Incident Report Number: 2021-3605
Registrant Reference Number: USA-BAYERBAH-2021-US0025925 (Report 707843)
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 YORK
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar Large
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Retriever-Golden/Shepherd - Australian/Chow Chow Crossbred
1
Male
7
Unknown
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
Unknown / Inconnu
System
Unknown / Inconnu
Yes
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date post application, in approximately Jan 2015, the dog developed an application site mass. The dog was evaluated by the veterinarian, and was diagnosed with lymphoma. The dog was given an unspecified chemotherapy drug via the unknown route. On an unspecified date in approximately Mar 2015, the dog died. No necropsy was performed.
Death
O - Unclassifiable/unassessable The reported application site mass may occur in sensitive animals after product application. It is usually mild and transient. Signs and time to onset are consistent. Further reported lymphoma 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 - 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. Time to onset is long. However, involved dog may have likely died due to underlying conditions. Previous exposure was well tolerated without any adverse event. Considering the product profile, product involvement is deemed unlikely, however due to limited information, (e.g. health status, medical history and necropsy report are unknown), case is considered as unassessable.