New incident report
Incident Report Number: 2015-6308
Registrant Reference Number: 2015KP314
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 Matheson Boulevard
City: Missisaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Domestic Animal
Country: UNITED STATES
Prov / State: UNKNOWN
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar - Small Dog
Other (specify)
CollarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Rat Terrier
1
Female
12
15
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 16Jun2015, the dog became lethargic, anorexic and adipsic so she was taken to an emergency clinic where an unspecified blood panel was performed. The dog was diagnosed with renal failure. It is unknown if medical treatments were sought, but the dog passed away. A necropsy was not performed. No further information expected. Case closed.
Death
Reported systemic signs such as lethargy, anorexia, adipsia are unspecific and may have various potential causes. These signs are likely associated with later diagnosed renal failure. Renal failure is not expected as not consistent with pharmaco-toxicological product profile. Moreover renal failure may be related with advanced age of animal. Subsequent death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause serious signs or death either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Additionally death is likely associated with renal failure. Overall, considering the known product profile and time to onset, sufficient information exists to conclude that the product did not cause the event even though not necropsy was performed. Finally, product involvement was ruled out.