New incident report
Incident Report Number: 2017-2225
Registrant Reference Number: 2017KP165
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
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
Other
Dog / Chien
Miniature Dachshund
1
Female
12
16
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>24 hrs <=3 days / >24 h <=3 jours
System
>24 hrs <=3 days / >24 h <=3 jours
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 27Nov2016, the dog died. It was unknown if the dog was examined by a veterinarian and it was unknown if a 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 phone call was to discuss the use of the product and not to report the death of the patient. No further information is expected. This case is closed.
Death
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 sign either. Animal involved in this case was geriatric with concomitant medical condition of cushings disease and distended abdomen, which probably the cause of the death. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (2.5 months). Product has wide margin of safety. Although an overdose was applied, a relation is considered unlikely. It is known that an overdose of 5 collars around the neck 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 did not cause serious signs. Moreover, the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Even though time to onset is short and no necropsy performed, sufficient information exists to rule out product relation completely. Finally, a product involvement is considered as unlikely.