New incident report
Incident Report Number: 2017-2229
Registrant Reference Number: 2017KP169
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
Blue Heeler Crossbreed
1
Female
6
27.7
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in Oct2016, the dog exhibited coughing and vomiting. The dog was examined by a veterinarian and unspecified treatments were 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. On an unknown date in Oct2016, the dog died. No necropsy was performed.
Death
Reported vomiting is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility).Mild gastrointestinal signs may occur shortly after product application, however time to onset is too long with 3 month. No oral product exposure reported. Coughing is not expected with product use. However, it may be associated with vomiting. Further, 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 owner does not believe in product connection, as 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, no necropsy was performed sufficient information exists to rule out product involvement. Time to onset is long. Finally, a product involvement is considered as unlikely.