New incident report
Incident Report Number: 2018-1602
Registrant Reference Number: USA-BAYERBAH-2018-US0006779 (Report 473122)
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: ALABAMA
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Dog unspecified
Other (specify)
COLLARYes
Other Units: Collar
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Welsh Corgi Pembroke
1
Unknown
15
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 25-Nov-2017, the dog died due to unknown circumstances. No known 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 the use of Seresto on the owner's current pet and not to report the death of the patient. No further information is expected. This case is closed.
Death
N-Unlikely: 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 signs of anaphylaxis reported. Other unrelated causes are more probable in this geriatric dog. Moreover, the reason for the initial call was to discuss the use of collar on the current pet and not to report the death of the patient. Even though some information is missing (e.g. exact time to onset), considering the known product safety profile and unexpected fatal outcome, product involvement is considered unlikely.