New incident report
Incident Report Number: 2017-4458
Registrant Reference Number: USA-BAYERBAH-2017-US0025364
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
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
Unknown
1
Unknown
Unknown
Unknown
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 mo <=2 mos / > 1 mois < = 2 mois
System
>3 days <=1 wk / >3 jours <=1 sem
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 01-Oct-2016, a canine of unknown signalment and condition, with no known concomitant medical conditions, had one Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On approximately 23- Nov-2016, the canine was examined by the veterinarian and diagnosed with lymphoma. On approximately 30-Nov-2016, the canine died; no known necropsy was performed. The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. No further information is expected. The case is closed.
Death
N - Unlikely 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 serious signs either. Additionally, overdose of 5 collars around the neck of adult dogs for an 8 months period and in 7 week old puppies for a 6 months period did not cause serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset is very long. Death may be the consequence of earlier diagnosed lymphoma in an animal. Further the owner did not believe in product involvement either as the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Even though some information (e.g. animal details, health condition, medical history and necropsy report) is not available, considering chronology and known safety profile of the product, a product relation is unlikely.