New incident report
Incident Report Number: 2018-2066
Registrant Reference Number: USA-BAYERBAH-2018-US0014725 (Report 479985)
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: PENNSYLVANIA
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
Unknown
Animal's Owner
Dog / Chien
unknown
1
Female
Unknown
Unknown
Skin
>3 days <=1 wk / >3 jours <=1 sem
>3 days <=1 wk / >3 jours <=1 sem
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 24-Apr-2017 the dog died. No necropsy was performed. Due to the sensitive nature of the communication, specific relevant details were not obtained, nor will they be sought. The reason for the initial communication was to discuss the expiration date of the product and not to report the death in this event. No further information is expected. This case is closed.
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. Moreover, the reason for the initial communication was to discuss the expiration date of the product and not to report the death in this event. In case of suspected involvement, sign would have been reported in close proximity and not a long time. Time to onset is long. Although, no necropsy was performed, considering known product profile a product relation is unlikely.