New incident report
Incident Report Number: 2017-4043
Registrant Reference Number: USA-BAYERBAH-2017-US0014421
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: FLORIDA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-122
Product Name: Advantage 100
Other (specify)
Spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
No
Animal's Owner
Cat / Chat
Unknown
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 details were not obtained nor will they be sought On an unknown date, in approximately 2011, a feline of unknown signalment and condition, with no known concomitant medical conditions, was administered an unknown amount of Advantage 100 topically by the owner. This product is meant to be applied to canines only. On an unknown date post application, in approximately 2011, the dog died due to an unknown cause. No necropsy was performed. The caller contacted Bayer Animal Health to inquire about using a different product on their pet and not to report this event. No more information is expected and the case is closed. Follow up Information 18 April 2017: On an unknown date, in approximately 2011, a feline of unknown signalment and condition, with no known concomitant medical conditions, was administered an unknown amount of Advantage 100 Topical Solution (Imidacloprid) topically by the owner. This product is meant to be applied to canines only.
Death
N - Unlikely Off-label use as dog product applied on cat. Death is not anticipated with appropriate product use as inconsistent with the pharmaco-toxicological product profile. No signs of allergic/anaphylactic reaction reported. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (approximately 6 years). Moreover, the information regarding the death of the cat was casually provided during an inquiry, the caller contacted Bayer Animal Health to inquire about using a different product on their pet and not to report death. Overall, even though low level of information is provided (animal details, medical history, time to onset and necropsy not available), considering the safety profile of the product and intent of the caller, a product relation is unlikely.