New incident report
Incident Report Number: 2017-6519
Registrant Reference Number: USA-BAYERBAH-2017-US0050780
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: PENNSYLVANIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: Advantage pipette size unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: K9 Advantix Spot-on pipette size 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
Labrador Retriever
1
Unknown
Unknown
Unknown
Skin
Unknown / Inconnu
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in 2005, a Labrador Retriever canine, of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage (dog-unspecified) (Imidacloprid) topically by the owner. On an unknown date in approximately 2011, the canine was administered 1 tube of K9 Advantix (unspecified) (Imidacloprid - Permethrin) topically by the owner. On an unknown date in 2014, the canine was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. On an unknown date in 2014, the canine died. It is unknown if the canine was euthanized or if a necropsy was performed. No further information is expected. This case is closed. 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 a suspected flea efficacy issue with another Bayer product with current household dog and was not to report the death of the patient. Note: Previous application well tolerated.
Death
Advantage Spot-on pipette size unknown 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 9 years). Moreover, reason for the initial call was to discuss a suspected flea efficacy issue with another Bayer product with current household dog and was not to report the death of the patient. Time to onset of 9 years is much to long. Considering the known safety profile of the product and intent of the caller and time to onset, a product relation is unlikely. Advantix Spot-on pipette size unknown N - Unlikely Reported death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Other etiologies more probable. Very long time (3 years) for reporting as the intent of the call communication was to discuss a suspected flea efficacy issue with another Bayer product with the current household dog and was not to report this event. Considering too long time to onset of 3 years, product connection is deemed to be unlikely. Advantix Plus Spot-on pipette size unknown N - Unlikely Reported death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Other etiologies more probable. Moreover the intent of the call communication was to discuss a suspected flea efficacy issue with another Bayer product with the current household dog and was not to report this event. Even though exact 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. Considering all aspects, product connection deemed to be unlikely.