New incident report
Incident Report Number: 2017-4026
Registrant Reference Number: USA-BAYERBAH-2017-US0023931
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: UNKNOWN
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar Small
Other (specify)
collarYes
Other Units: cm
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Shih Tzu
1
Male
6
3.856
kg
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 mo <=2 mos / > 1 mois < = 2 mois
System
>8 hrs <=24 hrs / > 8 h < = 24 h
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 15-Mar-2017, a 6 year old, approximately 8.5 pound, neutered, male, Shih Tzu canine, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Small Dog collar (Flumethrin-Imidacloprid) placed around the neck by the owner. On approximately 11-May-2017, the canine was comatose; the collar was removed. Shortly after removing the collar the canine died; no necropsy was performed. No further information is expected. This case is closed.
Death
N - Unlikely The product is not anticipated to cause serious disorders such as coma after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. Similarly serious sign like death is also not expected as per the product profile. 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. Even with oral product exposure, serious signs are not seen. Merely gastrointestinal signs may occur. Other causes are more probable. Time to onset is long and not suggestive of product involvement either. The product was used before without causing any adverse signs. Even though necropsy results are unknown, considering the product profile and all aspects, a product involvement is considered unlikely.