New incident report
Incident Report Number: 2020-0801
Registrant Reference Number: USA-BAYERBAH-2020-US0006502 (Report 622290)
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: CONNECTICUT
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: K9 Advantix II pipette size unknown
Other (specify)
Spot-onYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Schipperke
1
Female
Unknown
Unknown
Skin
Unknown / Inconnu
>30 min <=2 hrs / >30 min <=2 h
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Approximately 2 hours post application the dog exhibited 1 seizure that resolved approximately 5 minutes post onset. On an unknown date in 2015, approximately 1 day post application, the dog was lethargic. On an unknown date in 2015, post onset, the lethargy resolved. On an unknown date in approximately 2015, the dog died and no necropsy was performed. It was unknown if the dog was examined or treated by a veterinarian. The intent of the call was to inquire about product use in general and not to report this event. No further information is expected and this case is closed.
Death
O - Unclassifiable/unassessable Although product (containing a type I pyrethroid) may cause mild transient neurological signs. Reported seizure is not expected following product use. Secondly, dermal absorption is minimal. Other causes should be considered, e.g. idiopathic epilepsy, trauma, neoplasm. Although time to onset is consistent, seizure may rather be coincidental. Lethargy is an unspecific sign and may be associated with reported neurological sign. Later reported death after product application is not expected in dogs, as it is inconsistent with the pharmaco-toxicological profile of the product. Reliability of the report is questionable, due to very low level of information (age, medical history and time to onset unknown, necropsy not available). In fact, the intent of the phone call to Bayer was to inquire about product use in general and not to report this event. Other etiologies are likely. Though time to onset is consistent for initial signs it is unknown for later reported death. Considering overall aspects, a product connection for the case is unassessable.