New incident report
Incident Report Number: 2017-4457
Registrant Reference Number: USA-BAYERBAH-2017-US0025114
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
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-141
Product Name: K9 advantix II small dog
Other (specify)
spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Yorkshire Terrier
1
Female
3
2.268
kg
Skin
>8 hrs <= 24 hrs / >8 h <= 24 h
>8 hrs <=24 hrs / > 8 h < = 24 h
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 14-May-2017, a 3 year old, 5 pound, neutered, female, Yorkshire Terrier canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. On 15-May-2017, the canine exhibited a seizure and passed away; no necropsy was performed. No further information is expected. This case is closed. Note: Dog tolerated previous applications well.
Death
O - Unclassifiable/unassessable It is known that, at recommended dosage, none of active ingredients in the product have the potential to provoke seizures in dogs neither alone nor in combination. Only mild neurological signs, e.g. tremors or ataxia, may occur even after licking. Dog tolerated previous applications well, without neurological signs. Thus other causes should be considered. Death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Death is may be due to reported seizures and other underlying causes should be considered. Though time to onset is consistent, considering all aspects, a product connection is unasessable.