New incident report
Incident Report Number: 2018-2076
Registrant Reference Number: USA-BAYERBAH-2018-US0016266 (Report 481508)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississauga
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
Domestic Animal
Country: UNITED STATES
Prov / State: VIRGINIA
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto large dog
Other (specify)
COLLARYes
Other Units: Collar
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Crossbred (Dog)
1
Male
13
24.948
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 27-Aug-2017, the dog died and the owner removed the collar. No necropsy was performed. No further information is expected. The case is closed. Due to the sensitive nature of the communication, specific relevant details were not obtained, nor will such be sought. The reason for the initial phone call was to discuss the product use on another animal and not to report the death in this event.
Death
N - Unlikely Death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious signs 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. Outcome was probably the consequence of concomitant medical condition of an unspecified liver cancer. Time to onset is long. Further, the reason for the initial phone call was to discuss the product use on another animal and not to report the death in this event. Even though no necropsy is available, sufficient information exists to rule out product involvement in the affected geriatric dog. Thus, product relation is considered to be unlikely.