New incident report
Incident Report Number: 2018-1606
Registrant Reference Number: USA-BAYERBAH-2018-US0007276 (Report 473467)
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: NORTH CAROLINA
Unknown
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
Unknown
Animal's Owner
Dog / Chien
Golden Retriever
1
Male
Unknown
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 an unspecified date in approximately Oct 2017, post application, the dog died. No necropsy was performed. It was unknown if medical intervention was sought. Due to the sensitive nature of the phone call communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial communication was to discuss use of the product and not to report the death in this event. No more information is expected. Case is closed. Note: Previous exposure was well tolerated by the animal.
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. Previous exposure was well tolerated by the animal. Other unrelated causes are more probable. Moreover, The reason for the initial communication was to discuss use of the product and not to report the death in this event. Even though some information is missing (e.g. exact time to onset, necropsy), considering the known product safety profile and unexpected fatal outcome, product involvement is considered unlikely.