New incident report
Incident Report Number: 2016-0703
Registrant Reference Number: 2015KP338
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: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: advantage spot-on (unknown)
Liquid
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Other
Cat / Chat
Unknown
1
Unknown
17
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>24 hrs <=3 days / >24 h <=3 jours
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
An unknown time post administration in Sep 2008, the cat died. No known 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 another product and not to report the death of the patient.
Death
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 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Cat involved in this case was geriatric, which may have contributed to death of the animal. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (7 years). Further, the owner did not believe in product involvement either as reason for the initial call was to discuss another product and not to report the death of the patient. Even though some information missing (necropsy report, exact time to onset, medical history, health status) considering overall aspects, a product relation is deemed to be unlikely.