New incident report
Incident Report Number: 2018-1617
Registrant Reference Number: USA-BAYERBAH-2018-US0008892 (Report 474822)
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: K9advantixII pipette size unknown
Other (specify)
spot-onYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
German Shepherd Dog
1
Female
Unknown
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
<=30 min / <=30 min
System
Persisted until death
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Immediately post application, the dog exhibited spinning (behavior). Approximately 2 days post application, in Jan2016, the spinning resolved. On an unspecified date post application, in Jan2016, the dog was seen by a veterinarian, diagnosed with kidney failure and liver failure, and 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 reason for the initial communication was to discuss use of the product and not to report the death in this event. No further information is expected. This case is closed. Note: Previous applications were well tolerated.
Death
N - Unlikely - Reported spinning behavior is unspecific sign and may have other causes. Later diagnosed kidney failure, liver failure and further reported death are not expected after product application as inconsistent with pharmaco-toxicological profile of the product. Very long time for reporting ( 2 years) as the reason for the initial communication was to discuss use of the product and not to report the death in this event. Though time to onset is consistent for spinning it is unknown for further reported serious sign. Previous applications were well tolerated. Other underlying medical conditions more probable in dog. Considering the known product profile, a product connection is deemed to be unlikely.