New incident report
Incident Report Number: 2014-6115
Registrant Reference Number: 2014CK412
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Rd
City: Toronto
Prov / State: ON
Country: Canada
Postal Code: M9W 1G6
Domestic Animal
Country: UNITED STATES
Prov / State: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: Advantage uknown
Liquid
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Cat / Chat
unknown
1
Unknown
Unknown
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Persisted until death
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
At an unspecified time post application, the cat was hypersalivating.On an unspecified date post application, in approximately 2009, the cat died. It is unknown if a 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 phone call was to discuss the expiration date of remaining product and not to report the death of this patient
Death
Hypersalivation after suspected ingestion of product is consistent with distaste reaction, however, gastrointestinal sign if any would have occured short time after product application. Time to onset unknown in this case. Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. 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. Reliability of data is questionable due to limited information (product and animal details, medical history, chronology, necropsy not available). Other etiologies are more probable. Though time to onset unknown, in case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. No signs of allergy/anaphylactic reaction reported. Moreover, caller contacted Bayer Animal Health to inquire about using the remainder of the product on their new pet and not to report this event. Considering this, product involvement was unlikely.