New incident report
Incident Report Number: 2017-0575
Registrant Reference Number: 2017KP078
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 - Large Dog
Other (specify)
collarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Schipperke
1
Male
14
20
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Unknown / Inconnu
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in Jun2016, the canine was examined by a veterinarian, had an enlarged liver, had unspecified lab work performed and had elevated liver enzymes. It is unknown if treatments were performed. On 19Oct2016, the canine developed pruritus. On 01Nov2016, the canine 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 phone call was to discuss the use of the product and not to report the death of the patient. No more information is expected and this case is closed.
Death
The reported enlarged liver and elevated liver enzymes are not expected following appropriate topical product application as inconsistent with products pharmacological profile. Signs could be related to geriatric status of animal and dog reported to be in fair condition, with a concomitant medical condition of weight loss prior to treatment. Pruritus on other than the application site is not typically seen with topical product administration. Other causes (e.g. allergies) are more probable although not described. 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. Moreover, the intent of the call was to discuss the use of the product and not to report the death of the patient. Time to onset is long. Hence even though no necropsy was performed, considering chronology and the known safety profile of product sufficient information exists to rule out the product involvement. Finally, a product relation is deemed to be unlikely.