New incident report
Incident Report Number: 2018-5637
Registrant Reference Number: USA-BAYERBAH-2018-US0051327 (Report 517345)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
Domestic Animal
Country: UNITED STATES
Prov / State: NEW YORK
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
No
Animal's Owner
Dog / Chien
Retriever - Golden/Poodle (Unspecified) crossbred
3
Male
Female
0.0013
Unknown
Skin
>8 hrs <= 24 hrs / >8 h <= 24 h
>8 hrs <=24 hrs / > 8 h < = 24 h
System
<=30 min / <=30 min
No
No
Died
Other / Autre
specify Puppies were exposure to bitch wearing the collar
(eg. description of the frequency and severity of the symptoms
Approximately 12 hours after being born on 28-Aug-2018, three of the puppies had perianal burns (anal irritation) and died. No necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to discuss whether the remaining puppies should continue nursing. No further information is expected. This case is closed.
Death
O - Unclassifiable/unassessable Reported perianal burns is unspecific and may have numerous other causes. 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 oral exposure reported in this case. Further, Laboratory studies with either flumethrin or imidacloprid in rats and rabbits have not produced any effects on fertility or reproduction and showed no teratogenic, or foetotoxic effects. However, the safety of the veterinary medicinal product has not been established in target animals during pregnancy and lactation and in the absence of available data. Moreover, the reason for the initial call was to discuss whether the remaining puppies should continue nursing. Considering short time to onset and limited information about product exposure in puppies, a product involvement is unassessable.