New incident report
Incident Report Number: 2020-0447
Registrant Reference Number: USA-BAYERBAH-2020-US0002031 (Report 617933)
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: CONNECTICUT
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: Advantage Spot-on pipette size unknown
Other (specify)
Spot-onYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Cat / Chat
Domestic Longhair
1
Male
19
Unknown
Skin
Unknown / Inconnu
<=30 min / <=30 min
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Immediately post application, the cat exhibited application site alopecia and vocalization. The owner bathed the cat and vocalization resolved approximately 2 hours post onset. On an unspecified date in approximately 2011, the application site alopecia resolved. On an unspecified date in approximately 2015 the cat died of unknown causes. No necropsy was performed. No more information is expected. Case is closed.
Death
O - Unclassifiable/unassessable A dermal reaction such as alopecia at the application site in a particularly sensitive animal may occur. Reported vocalization is suggestive of behavioural response to the product sensation or to the product smell. Time to onset is short. Further reported death is not expected with topical product application. It is not inconsistent with pharmaco-toxicological product profile and experience. No oral exposure is reported. Oral exposure to the product is not expected to cause serious conditions leading to death. 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, animal died long time after product application. Other causes are likely in this geriatric animal (now 23 years old). Considering all aspects, a product relation for the case is unassessable.