New incident report
Incident Report Number: 2017-7473
Registrant Reference Number: USA-BAYERBAH-2017-US0065236 (Report 451738)
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: OHIO
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
Unknown
1
Female
Unknown
Unknown
Skin
>6 mos <=1 yr / > 6 mois < = 1 an
>6 mos / > 6 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 01-Mar-2017, the dog died. No necropsy was performed. 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 call was to discuss the use of Seresto in the owners current pet and not to report the death of the patient. No further information is expected. This case is closed.
Death
N-Unlikely: Death is 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. 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 is exceptionally long. Moreover, the reason for the initial call was to discuss the use of Seresto in the owners current pet and not to report the death of the patient. Finally, although no necropsy performed, considering the known product profile safety and long time to onset, product involvement is deemed to be unlikely. The reporting party did not contact Bayer Animal Health to report the death of the animal but to inquire about using Seresto in her current canine.