New incident report
Incident Report Number: 2019-5072
Registrant Reference Number: USA-BAYERBAH-2019-US0045885 (Report 588577)
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: TEXAS
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: advantageII pipette size 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
unknown
1
Unknown
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date post application, in 2017, the cat developed neoplasia. It was unknown if the cat was examined by a veterinarian or if any treatments were performed. An an unknown date in 2017, post application and post onset of the clinical sign, the cat died. It was not known if a necropsy was performed. Due to the sensitive nature of the communication, specific relevant details were not obtained, nor will such be sought. The intent of the call was to inquire about product use in general and not to report this event. No further information is expected. This case is closed. Note: The intent of the call was to inquire about product use in general and not to report this event.
Death
Advantage Plus Spot-on pipette size unknown O - Unclassifiable/unassessable Reported neoplasia and death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral exposure to the product is not expected to cause serious conditions leading to death. The product was administered to puppies/kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments and there were no serious safety concerns. Animal may have died because of neoplasia. Considering unknown time to onset, product relation for the case is unassessable. Advantage Spot-on pipette size unknown N - Unlikely Reported neoplasia and death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral exposure to the product is not expected to cause serious conditions leading to death. The product was administered to puppies/kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments and there were no serious safety concerns. Other causes are likely. Considering long time to onset (7 years), relation to product is unlikely.