New incident report
Incident Report Number: 2013-6265
Registrant Reference Number: 2013CK013
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. 25131 PMRA Submission No. EPA Registration No. 11556-130
Product Name: Advantage 100
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Cross Breed
1
Male
8
105
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Persisted until death
Yes
Yes
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 01Jul2011 the canine was examined by a veterinarian who performed magnetic resonance imagery and diagnosed him with a heart based tumor. On an unspecified date unknown anesthetics were administered and surgery was performed to remove the tumor. The canine passed away approximately 4 hours post surgery from blood loss (hemothorax). No necropsy was performed. T
Death
he owner called to determine if the product was still stable to use and if it had an expiration date, so she could return the product to her veterinarian to exchange for Advantage for her cat. The information regarding the death of the dog was casually provided during an inquiry. Heart based tumor and death are not expected, as inconsistent with pharmaco-toxicological product profile and experience. Product is only topically acting and has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Product has no oncogenic properties. No reaction on previous exposure. The dog died after a complication to a surgical procedure according to case description. Time of death too long after last exposure. Chronology inconsistent. Finally, a product relation can be completely excluded.