New incident report
Incident Report Number: 2016-6634
Registrant Reference Number: 2016KP180
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: advantage II unknown
Liquid
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Other
Cat / Chat
Unknown
1
Male
8
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
>8 hrs <=24 hrs / > 8 h < = 24 h
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in 2016, the cat developed pruritus and fleas. On 09-Sep-2016, the cat was administered an unknown dose of a cortisone injection by the attending Veterinarian. The cat also had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck by the owner. Approximately 8 hours post application the cat seemed to have difficulty breathing, the cat was not examined by a veterinarian. On 10Sep2016, the cat died. It is unknown if a necropsy was performed. No more information is expected this case is closed.
Death
Pruritus is not expected with appropriate topical product use. If any, skin reactions would be located at the application site. Time to onset is unknown. Reported breathing difficulty and subsequent death are not expected after topical application of product, moreover these sign occurred in close proximity of another product application. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24-fold over dosage tolerated by cats without showing any side effect. Time to onset exceptionally long. However, presence of fleas is not a sign of inefficacy. Regular treatments for at least a 6-week period are necessary in order to break the flea development circle. Otherwise preexisting pupae may still emerge from the environment and re-infest the pet. Efficacy against fleas can be expected only after this period. In the end SLEE not evident. Moreover, serious sign occurred long time after treatment and in close proximity to another product application. Overall, a product involvement is considered unlikely.