New incident report
Incident Report Number: 2017-4048
Registrant Reference Number: USA-BAYERBAH-2017-US0014873
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
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar Small Dog
Other (specify)
Spot-onYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Maltese
1
Male
14
6.577
kg
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in 2017, a 14 year old, 14.5 pound, neutered, male, Maltese canine, in unknown condition, with a concomitant medical condition of Cushing's disease, had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around his neck by the owner. On an unspecified date post application, in 2017, the collar was removed for an unknown reason. On an unspecified date post removal, in 2017, the canine died. No known necropsy examination 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 the efficacy 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 products 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. Moreover, death was reported after product withdrawal. Animal invovled in this case was geriatic with concomitant history of cushings disease. Further, The reason for the initial call was to discuss the efficacy of the product and not to report the death in this event. Even though some information (e.g. health status, time to onset and necropsy results) is not available, considering the known product profile and serious outcome of the case, a product involvement is deemed to be unlikely.