New incident report
Incident Report Number: 2017-4003
Registrant Reference Number: USA-BAYERBAH-2017-US0017638
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: 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
Male
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Other / Autre
specify Unknown
(eg. description of the frequency and severity of the symptoms
On an unspecified date in approximately 2011, a male, Shih Tzu canine, of unknown age, weight and reporductive condition, in unknown condition, with concomitant medical conditions of fleas, was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. On an unspecified date in 2011, post the application the dog developed application site hot spots. The dog was not examined for the sign by a veterinarian and the issue resolved. On an unspecified date in approximately 2013 the dog died of unspecified causes; no necropsy was performed. No further information is expected, this case is closed. The reporting party contacted Bayer Animal Health to inquire about use of the product for an active flea infestation and not report the death of this animal. Follow up received on 24th Apr 2017: On an unspecified date in 2011, post the application the dog developed application site hot spots. The dog was not examined for the sign by a veterinarian and the issue resolved on an unknown date in 2011.
Death
N - Unlikely Whereas skin reaction at application site, e.g. pruritus or erythema may occur in sensitive animals, would not expect pyoderma development directly related to product. However, likely linked to scratching at application site which caused skin lesions by self-trauma, which secondarily became infected with bacteria. Death not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Very low level of information (age, medical history and time to onset unknown - necropsy not available) as the intent of the phone call to Bayer was to ask if the remaining product could be used on a new pet, and not to report the death of the patient. Other etiologies more probable. No signs of allergy/anaphylactic reaction reported. Even though time to onset unknown, occurrence of sign within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity. Time to onset though unknown for initially reported sign, it is too long (approx. 2 years) for later reported death. Considering all aspects, product connection deemed to be unlikely.