New incident report
Incident Report Number: 2017-6509
Registrant Reference Number: USA-BAYERBAH-2017-US0048667
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: Advantage pipette size unknown
Other (specify)
Spot-onYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
English Cocker Spaniel
1
Male
14
Unknown
Skin
Unknown / Inconnu
>2 hrs <=8 hrs / > 2 h < = 8 h
System
Unknown / Inconnu
Yes
Unknown
Died
Other / Autre
specify Unknown
(eg. description of the frequency and severity of the symptoms
In approximately 2010, an approximately 14 year old, male, Cocker Spaniel canine, of an unknown weight, reproductive status, and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage (unspecified) (Imidacloprid) topically by the owner. Approximately 6 hours post application, the dog was found collapsed and had urinated. The urine had a chemical odor. The dog was taken to a veterinarian, where he was treated with an unknown injection and bathed twice. On an unspecified date post application, in 2011, the dog died. No known necropsy was performed. No further information is expected. Case is closed. Note: The intent of the call was to discuss product use on another pet and not to report the death of the dog.
Death
N - Unlikely Collapse is not expected to occur with topical product application as inconsistent with product pharmaco-toxicological profile. No oral exposure reported. Inappropriate urination may be associated with the collapse. Chemical odor of the urine is not expected too and may have multiple other causes (e.g. diet). It must be considered that odor is subjective to the concerned individual. Time to onset is short. Further, reported death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Other unrelated etiologies are more probable. Product has wide margin of safety. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (6 years). Moreover, the intent of the phone call was to discuss product use on another pet and not to report the death of this geriatric dog. Overall, even though some details are missing (e.g. necropsy, time to onset for death), considering fatal outcome and known safety profile of the product, product connection is ruled out.