New incident report
Incident Report Number: 2015-4044
Registrant Reference Number: 2015KP071
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 Matheson Blvd. East
City: Mississauga
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 (unknown size)
Liquid
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Other
Dog / Chien
Fox Terrier (smooth)
1
Male
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 2011, the canine died of unspecified renal issues and other unknown age related issues. It was unknown if a necropsy examination was performed.
Death
Due to the sensitive nature of the communication, specific event details were not obtained, nor will such be sought. The reason for the initial call was to discuss the use of another Advantage product on current pets and not to report the death of this pet. No further information is expected. This case is closed. Renal disorder and subsequent death are not expected after product application, as inconsistent with pharmacotoxicological product profile. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 20-fold over dosage tolerated by dogs without showing any side effect. No signs of allergy/anaphylactic reaction reported either. Rather, the canine died of unspecified renal issues and other unknown age related issues. Time to onset though not exactly known, is evidently very long (almost one year). Moreover, in case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (almost four years later). Rather, the reason for the initial call was to discuss the use of another Advantage product on current pets and not to report the death of this pet. Considering all these aspects, in spite of some information missing (e.g. necropsy, animal and product details), a product relation is deemed to be unlikely.