New incident report
Incident Report Number: 2017-4949
Registrant Reference Number: USA-BAYERBAH-2017-US0044611
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
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto (unspecified)
Other (specify)
CollarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Lhasa Apso
1
Unknown
Unknown
Unknown
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
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 2016, approximately 1 month post application, the collar was removed for an unknown reason. On an unknown date in 2017, the canine died. It was unknown if necropsy was performed.
Death
Case is closed. The reason for the initial call was to discuss use of the product not to report the death in this event. 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset is long. However, death occurred unknown time after collar removal. Other causes are more probable. The intent of the call was to discuss use of the product not to report the death in this event. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. Though some information is not available (necropsy report and animal details), sufficient information exists to rule out product involvement completely. Overall, product involvement is unlikely.