New incident report
Incident Report Number: 2018-5465
Registrant Reference Number: USA-BAYERBAH-2018-US0044906 (Report 510793)
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: TENNESSEE
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
unknown
1
Unknown
14
Unknown
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 01-Mar-2018, the dog died. It is unknown if a necropsy was performed. Due to the sensitive nature of the communication, specific relevant details were not obtained, nor will they be sought. Note: Previous product application was well tolerated. The intent of the call was not to report this event but to inquire about product use on another dog. This case is closed. No further information is expected.
Death
N - Unlikely Reported 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 which would have occurred in close proximity to the collar application. Moreover, the intent of the call to Bayer was not to report this event but to inquire about product use on another dog. Also, previous product application was well tolerated. Other causes are more probable in this geriatric dog. Time to onset long. Considering the known product profile sufficient information exists to conclude that the product did not cause the event and product involvement is deemed to be unlikely.