New incident report
Incident Report Number: 2019-5082
Registrant Reference Number: USA-BAYERBAH-2019-US0049402 (Report 592115)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Domestic Animal
Country: UNITED STATES
Prov / State: OHIO
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Large Dog collar
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Crossbred (Dog)
1
Female
13
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>3 days <=1 wk / >3 jours <=1 sem
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 27-Jun-2019, the dog exhibited vomiting, difficulty breathing, and unspecified behavior changes (behavioral disorder NOS). On approximately 28-Jun-2019, the dog died. No known necropsy was performed.
Death
O - Unclassifiable/unassessable Reported behavioural sign is unspecific and may have numerous other causes. Sign may occur initially after collar administration. Time to onset is consistent. Breathing difficulty is not expected after appropriate product application. Additionally, vomiting is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Though mild gastrointestinal signs may occur shortly after product application, they are not expected to appear with long time to onset. No oral product exposure reported. Further, 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Other unrelated causes must be considered in this geriatric animal. Time to onset is long. Considering no necropsy report and cause of death is unknown, the case is considered as unassessable.