New incident report
Incident Report Number: 2017-6543
Registrant Reference Number: USA-BAYERBAH-2017-US0037800
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: MINNESOTA
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
No
Animal's Owner
Dog / Chien
Yorkshire Terrier
1
Male
16
2.948
kg
Skin
Unknown / Inconnu
>2 mos <=6 mos / > 2 mois < = 6 mois
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in Oct 2016, an approximately 16 year old, approximately 6.5 pound, neutered, male, Yorkshire Terrier canine, in unknown condition, with no known concomitant medical conditions, was administered 0.26 ml of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. This was an extra-label use of product as only a partial pipette was administered. On an unspecified date in Mar2017, the canine died. It is unknown if the canine was euthanized or if a necropsy was performed. No further information is expected. This case is closed. 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 call was to discuss product use on her other dogs and not to report the death of the patient.
Death
N - Unlikely Death is not expected in dog after product application as inconsistent with pharmaco-toxicological product profile. Other causes are more likely in this geriatric dog. Low level of information (medical history, and necropsy details are unknown), as the intent for the initial call was to discuss product use on her other dogs and not to report the death of the patient. Though exact time to onset is unknown it seems long (5 months). Considering overall aspects, a product connection is deemed to be unlikely.