New incident report
Incident Report Number: 2018-5628
Registrant Reference Number: USA-BAYERBAH-2018-US0050888 (Report 516957)
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 II pipette size unknown
Other (specify)
Spot-onYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Cat / Chat
Unknown
1
Unknown
Unknown
Unknown
Skin
Unknown / Inconnu
>3 days <=1 wk / >3 jours <=1 sem
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in approximately 2016, the cat was lethargic, disoriented and had generalized pruritus. Approximately 4 days post application, in approximately 2016, the clinical signs resolved without medical intervention. On an unknown date post application, in approximately 2016, the cat died. No known necropsy was performed. No more information is expected. This case is closed. The initial communication with Bayer Animal Health was to discuss product use on additional animals and not to report the death of this feline.
Death
O - Unclassifiable/unassessable Reported lethargy and disorientation are unspecific and may have various other causes. Pruritus on other than the application site is not anticipated with topical product administration. If any, skin reactions would be localized at the application site. Time to onset is unknown, however less than 4 days. Further reported death is inconsistent with pharmaco-toxicological product profile and experience. 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. Moreover, the initial communication with Bayer Animal Health was to discuss product use on additional animals and not to report the death of this feline. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (approximately 2 years). Time to onset is too long for death. Other causes are likely. Overall, a product relation is unassessable.