New incident report
Incident Report Number: 2017-4041
Registrant Reference Number: USA-BAYERBAH-2017-US0014305
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
Dog / Chien
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 canine of unknown signalment and condition, with no known concomitant medical conditions, was administered an unknown amount of Advantage (dog-unspecified) (Imidacloprid) topically by the owner. This product is not labeled to be dosed in this manner. 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 10th April 2017: On an unknown date, in approximately 2011, a canine 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 was extra label use as the product is not intended to be applied as a partial dose.
Death
N - Unlikely Death is inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. No signs of allergic/anaphylactic reaction reported. 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 dog was casually provided during an inquiry as 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.