New incident report
Incident Report Number: 2019-1873
Registrant Reference Number: USA-BAYERBAH-2019-US0007122 (Report 549365)
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: HAWAII
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: advantageII pipette size unknown
Other (specify)
spot-onYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Australian Shepherd Dog
1
Male
6
35.45
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in approximately 2014, the canine was diagnosed with bone cancer. On 01-May-2016, the canine died. It is unknown if a necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The intent of the call was to inquire about product use in general and not to report this event. No more information is expected. Case is closed.
Death
N - Unlikely The information regarding the death of the dog was casually provided during an inquiry. The level of information is very low. Nevertheless bone cancer and death are inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Animal died may be due to diagnosed bone cancer. The product has no carcinogen potential. A product relation can be excluded completely. Time to onset is long. Moreover, in case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (2.5 years). Even though no necropsy was performed, considering all aspects, a product relation is unlikely.