New incident report
Incident Report Number: 2016-7966
Registrant Reference Number: 2016KP247
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 Collar
Other (specify)
collarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
German Shepherd
1
Male
9
100
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>3 days <=1 wk / >3 jours <=1 sem
System
>1 wk <=1 mo / > 1 sem < = 1 mois
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Approximately 7 days post application, in Jul-2016, the canine exhibited worsening congestive heart failure. The collar was removed. Approximately 10 days post application, in Jul-2016, the canine died. The canine was not evaluated by a veterinarian. Limited information was obtained at the time of the communication. Further attempts to gather additional information will not be made. The reporting party contacted Bayer Animal Health to inquire about a replacement collar and not to report the death of this animal. No known necropsy was performed. No further information is expected. Case is closed.
Death
Reported congestive heart failure is not expected after product application as inconsistent with products pharmacological profile. Moreover, sign was pre-existing prior to product application thus worsening of same is not expected. Death is also 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 involved in this case likely died due to worsening of congestive heart failure. The reporting party contacted Bayer Animal Health to inquire about a replacement collar and not to report the death of this animal. Time to onset is long. Even though no necropsy was performed, sufficient information exists to rule out product relation completely. Finally, a product involvement is considered unlikely.