New incident report
Incident Report Number: 2017-4464
Registrant Reference Number: USA-BAYERBAH-2017-US0026215
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 unknown
Other (specify)
collarYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Unknown
1
Unknown
Unknown
Unknown
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 unknown date in approximately 2016, a dog of unknown signalment, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Dog collar (unspecified) (Flumethrin-Imidacloprid) placed around the neck by the animal owner. On an unknown date after collar placement in 2016, the dog developed pruritus. On an unknown date after collar placement in 2016, the dog 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 phone call was to discuss the use of the product and not to report the death of the patient. No further information is expected. This case is closed.
Death
N - Unlikely Pruritus at sites other than the application site is not typically seen with topical product administration. Other causes (e.g. allergies) are more probable although not described. 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. Further, the owner did not believe in product involvement either as the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. In case of suspected involvement signs would have been reported in close proximity to the event and not a long time later. Considering all aspects, in spite of some missing information (animal details, time to onset, absence of necropsy results and unknown medical history of the dog), product involvement is deemed to be unlikley.