New incident report
Incident Report Number: 2015-6103
Registrant Reference Number: 2015KP222
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 Matheson Blvd. East
City: Mississauga
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 (unknown size)
Liquid
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Other
Cat / Chat
unknown
1
Female
Unknown
11
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date post administration in approximately 2009, the cat was 5 pounds and was diagnosed with pancreatic neoplasia. On an unknown date in 2009, the cat no longer was able to jump up on furniture (muscle weakness). One month later, the cat became agonal and died. No necropsy was performed. No further information is expected. This case is closed. 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 a current flea infestation and not to report the death of the patient.
Death
Neoplasia and death are inconsistent with pharmacotoxicological product profile and experience. Weight loss, muscle weakness and respiratory arrest is the consequence of diagnosed pancreatic neoplasia leading to death. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. The cause of death was a neoplasia. The product has no carcinogen potential. The reason for the initial call was to discuss a current flea infestation and not to report the death of the patient. Exact time to onset unknown, however, treatment and signs/death occurred in different years. Therefore, a product relation can be excluded completely and considered as unlikely.