New incident report
Incident Report Number: 2016-6699
Registrant Reference Number: 2016KP257
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
Other (specify)
collarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Jack Russell Terrier
1
Male
12
17
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
System
Unknown / Inconnu
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 18Aug2016, while the canine was being boarded, the concurrent medications were not administered and the canine died. It was unknown if a necropsy examination was preformed. 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 the product on another pet and not to report the death of this canine. 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 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. Animal involved in this case was geriatric, poor in condition and had concomitant medical conditions of complete heart block, positive test for Lyme Disease, bradycardia and ascites which may have further contributed to death of the animal, especially as concurrent medications were not administered. Moreover, reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Time to onset is also not suggestive of product relation either. Even though no necropsy report is available, sufficient information exist to rule out product relation completely and product relation is considered as unlikely.