New incident report
Incident Report Number: 2018-5484
Registrant Reference Number: USA-BAYERBAH-2018-US0046149 (Report 512146)
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: NEW YORK
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: advantageII 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
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in approximately 2017, post administration, the cat died due to unknown circumstances. 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 call was to discuss the use of the product in the owner's current cats and not to report the death of the patient. No further information is expected. This case is closed. Note: Previous exposure was well tolerated by the animal.
Death
N - Unlikely Death is inconsistent with pharmaco-toxicological product profile and experience. No signs of allergic/anaphylactic reaction reported. 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 reason for the initial call was to discuss the use of the product in the owner's current cats and not to report the death of the patient. Previous exposure was well tolerated by the animal. Even though some information (time to onset and necropsy) is missing, considering the safety profile of the product and intent of the caller, a product relation is unlikely.