New incident report
Incident Report Number: 2017-4054
Registrant Reference Number: USA-BAYERBAH-2017-US0015669
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: MASSACHUSETTS
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
Shih Tzu
1
Unknown
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
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 the product for another pet and not to report the death of the patient. On an unknown date in approximately 2011, a Shih Tzu canine, of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. On an unknown date, in approximately 2016, the 16 year old canine died from unknown causes. It is unknown if a necropsy was performed. No further information expected. Case closed.
Death
N - Unlikely Death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Very low level of information (age, medical history and necropsy not available) as the intent of the phone call to Bayer was to discuss the product for another pet and not to report the death of the patient. No signs of allergy/anaphylactic reaction reported. Occurrence of sign within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity and not long time after. Time to onset is too long (5 years) for product involvement. Other causes more probable in this geriatric dog. Considering all aspects, product connection deemed to be unlikely.