New incident report
Incident Report Number: 2018-6729
Registrant Reference Number: USA-BAYERBAH-2018-US0066042 (Report 532531)
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
Shih Tzu
1
Female
Unknown
2.268
kg
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>8 hrs <=24 hrs / > 8 h < = 24 h
System
Persisted until death
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Approximately 24 hours post application, in Jun2017, the dog developed loose stool. Approximately 3 days post application, in Jun2017, the loose stool resolved. On an unspecified date in Jun2017, the dog developed seizures, lethargy, and vomiting. The owner continued to apply monthly applications of K9 Advantix II with the last known dose in approximately Nov2017. On 23Nov2017,the dog died. It is unknown if a necropsy was preformed. No further information is expected. This case is closed.
Death
O - Unclassifiable/unassessable Reported loose stool is an unspecific sign and may have numerous other causes. Association in time. It is known that, at recommended dosage, none of active ingredients in the product have the potential to provoke seizures in dog neither alone nor in combination. Only mild neurological signs, e.g. tremors or ataxia, may occur even after oral uptake. Onset time seems rather long, i.e. more than 3 days. Lethargy and vomiting may be associated with reported seizures. Further reported death on subsequent product application is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Reliability is questionable due to very low level of information (age and necropsy not available). Other causes should be considered. Considering overall aspects, a product connection is unassessable.