New incident report
Incident Report Number: 2017-6511
Registrant Reference Number: USA-BAYERBAH-2017-US0049102
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
Domestic Animal
Country: UNITED STATES
Prov / State: ILLINOIS
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Large Dog
Other (specify)
COLLARYes
Other Units: Collar
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Saluki
1
Unknown
Unknown
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 unknown date in 2017, a Saluki canine of unknown signalment, in unknown condition, with no known concomitant medical conditions, had one Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On on an unknown date in 2017, the canine had cancer and died. It is unknown if medical attention was sought. No known necropsy was performed. No further information is expected case is closed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Note: Previous exposure was well tolerated by animal.
Death
N - Unlikely Reported 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 serious signs either. Animal likely died due to cancer. Previous exposure was well tolerated by animal. Moreover, the intent of the phone call to Bayer was to ask use of the product and not to report the death of the patient. Finally, even though some information (e.g. time to onset and necropsy results) not available, considering known product profile, a product involvement is deemed to be unlikely.