New incident report
Incident Report Number: 2017-4935
Registrant Reference Number: USA-BAYERBAH-2017-US0041686
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: PENNSYLVANIA
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar Large Dog
Other (specify)
CollarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Pit Bull crossbred
1
Male
3
40.823
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 10-Jun-2017, a 3 year old, 90 pound, neutered, male, Pit Bull crossbred dog, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On approximately 24-Jun-2017, the dog was examined by a veterinarian who diagnosed an unspecified neoplasia. On 08-Jul-2017 the dog died. No known necropsy was performed. No more information is expected. This case is closed.
Death
N - Unlikely The reported serious signs 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. Time to onset long. Moreover fatal outcome of death likely related to diagnosed unspecific neoplasia. Overall, even though no necropsy result available, considering known product profile, sufficient information is available to rule out product relation and consider as unlikely.