New incident report
Incident Report Number: 2016-2717
Registrant Reference Number: 2016KP035
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. Unknown
Product Name: advantage II - unknown
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Other
Dog / Chien
Dachshund (Standard) - Kurzhaar
1
Female
Unknown
Unknown
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 2014 the animal died. No necropsy was performed. Due to the sensitive nature of the communication, limited information was provided. The intent of the call was to discuss use of the product on another pet and not to report the death of the dog. No further information is expected. Case is closed.
Death
Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. No signs of allergic/anaphylactic reaction reported in close proximity of product application. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (2 years). Further, the owner did not believe in product involvement either as reason for the initial call was to discuss the use of product on another pet and not to report the death of the patient. In spite of the limited information (animal details and time to onset unknown, absence of necropsy results), no plausible connection can be made to the product knowing the safety profile of the product and thus product involvement is deemed to be unlikely.