New incident report
Incident Report Number: 2017-0686
Registrant Reference Number: 2017KP008
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. 11556-151
Product Name: advantage II small cat
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Other
Cat / Chat
Ragdoll Crossbreed
1
Male
14
17.5
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
<=30 min / <=30 min
System
>1 wk <=1 mo / > 1 sem < = 1 mois
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Immediately post administration, the feline exhibited lethargy. Approximately 36 hours post administration in Jul 2014, the lethargy resolved. On an unknown date post administration in Jul 2014, the feline began groaning and moaning (vocalization). The feline was taken to the veterinarian for an examination and during the car ride, the cat did not exhibited his normal behavior while riding in a car (behavioral nos). The feline was hospitalized and died overnight. Diagnostics and treatments are unknown and 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 product use on a stray cat and was not to specifically report the death of the patient.
Death
Initially reported lethargy is an unspecific sign and may have multiple potential other causes in an animal, it may represent a behavioural response to the product sensation. Time to onset is short. Moreover, the animal involved in this case had concomitant history of lethargy which may have contributed to the sign. Later reported vocalization and behavioural disorder are unspecific signs and may have various other causes. 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. Animal involved in this case was geriatric. In case of suspected product involvement event would have been reported in close proximity and not long time (almost 2 years) after. The reason for the initial call was to discuss product use on a stray cat and not to report the death of the patient. Even though some information is not available (exact time to onset for death and necropsy report), considering available information a product relation is unlikely.