New incident report
Incident Report Number: 2018-2720
Registrant Reference Number: USA-BAYERBAH-2018-US0031294 (Report 497188)
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: LOUISIANA
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-151
Product Name: advantageII small cat
Other (specify)
Spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
Crossbred (Cat)
1
Male
6
2.722
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 mo <=2 mos / > 1 mois < = 2 mois
System
Unknown / Inconnu
Yes
Yes
24
Hour(s) / Heure(s)
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 01-Mar-2018, the cat was also administered an unknown dose of Spinetoram via the topical route by the animal owner. On approximately 14-Mar-2018, the cat was evaluated by a veterinarian and subcutaneous fluids were administered. On approximately 15-Mar-2018, the cat died. No necropsy was performed. 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 communication was to discuss use of the product and not to report the death in this event. No more information is expected and this case is closed. Note: Previous exposure was well tolerated by animal.
Death
N - Unlikely Reported death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. 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. Previous exposure was well tolerated by animal. Moreover, the owner did not believe in product involvement either as the reason for the initial communication was to discuss use of the product and not to report the death in this event. Time to onset is long. Even though some information is not available (e.g. necropsy report), considering safety profile of the product, a product involvement is unlikely.