New incident report
Incident Report Number: 2013-4491
Registrant Reference Number: 2013AM234
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. 11556-144
Product Name: K9 Advantix II Extra Large Dog
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
unknown
1
Female
10
75
lbs
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Persisted until death
Yes
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 01-Oct-2012, a 10 year old, 75 pound, spayed, female, Mixed Breed canine, in fair condition, with a concomitant medical conditions of neurologic signs, with a history of lyme disease, ear infections, urinary tract infections, and bilateral anterior cruciate ligament ruptures, was administered 1 tube of K9 Advantix II Extra Large Dog (Imidacloprid-Permethrin- Pyriproxyfen) once topically by the owner. On an unknown date in Oct 2012 the dog was examined, had diagnostic bloodwork, and radiographs performed, with no abnormal results. The dog was prescribed an unknown dose of oral prednisone, which improved clinical sign. On 24-Oct-2012 the dog was scheduled for an MRI, the dog was found passed away in its cage. No necropsy was performed, but the owner stated the dog had a brain tumor.
Death
Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Other causes more probable. Brain tumor suspected. Dog in fair condition with concommitant neurological signs. The intent of the phone call to Bayer was to ask drug information concerning new dog, and not to report the death of the patient. Time to onset inconsistent. No necropsy performed. Considering all aspects, a product connection is deemed to be unlikely.