New incident report
Incident Report Number: 2021-2616
Registrant Reference Number: USA-BAYERBAH-2021-US0016584 (Report 697307)
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: NORTH CAROLINA
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto collar uknown
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Boxer (German Boxer)
1
Male
Unknown
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 30-Nov-2016, the dog developed skin irritation. The collar was removed and the dog was prescribed an unknown flea preventative by the veterinarian. On approximately 01-Dec-2016, the skin irritation resolved. On an unknown date in approximately Jun-2019, the dog was evaluated by a veterinarian, was diagnosed with heart failure, and had unknown treatments performed. On an unspecified date in approximately Apr-2020, 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. This case is closed, no further information is expected.
Death
O - Unclassifiable/unassessable Skin irritation on other than the application site is not typically seen with topical product administration. Other causes (e.g. allergies) have to be considered as well. But time to onset consistent. Initial pruritus may represent a reaction to the collar in a sensitive animal. The diagnosed heart failure and death are not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause such 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Death might be a consequence of heart failure. Heart failure and death reported long time (3 years) after collar removal. Additionally the reporting party did not call to report the death of this animal but to inquire about product use on another animal. Overall product relation is considered as unassessable.