New incident report
Incident Report Number: 2017-6517
Registrant Reference Number: USA-BAYERBAH-2017-US0050295
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. Unknown
Product Name: Advantage pipette size unknown
Other (specify)
Spot-onYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Miniature Pinscher
1
Male
0.25
Unknown
Skin
Unknown / Inconnu
>6 mos / > 6 mois
System
>6 mos / > 6 mois
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 03-Aug-2002, a 3 month old, of unknown weight, neutered, male, Pinscher (Miniature) canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage (dog-unspecified) (Imidacloprid) topically by the owner. On approximately 03-Aug-2012, the dog developed dermal masses on the back near the shoulder blades. On an unknown date in approximately 2014, the dog developed diabetes. On approximately 02-Aug-2016, the dog died due to unknown causes. No necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The initial communication from the reporting party was to inquire about using another product on a new pet and not to report this event. No further information is expected. This case is closed.
Death
N - Unlikely Reported dermal mass, diabetes and death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. time to onset inconsistent either. Product has wide margin of safety. Other etiologies are more probable in this geriatric dog. Moreover, the initial communication from the reporting party was to inquire about using another product on a new pet and not to report this event. Even though no necropsy was performed, considering all aspects, a product involvement is considered unlikely.