New incident report
Incident Report Number: 2021-3146
Registrant Reference Number: USA-BAYERBAH-2021-US0021413 (Report 702690)
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: PENNSYLVANIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto small dog
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Yorkshire Terrier
1
Male
7
1.814
kg
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Yes
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in approximately 2018, the dog exhibited abdominal distention. The dog was examined by a veterinarian and diagnosed with multi organ failure. The dog was started on an unspecified dose of oral furosemide. On an unknown date in approximately 2018, the dog was examined by a veterinary specialist, an ultrasound was performed and diagnosed with ascites. The clinical signs continued. On an unknown date in approximately 2018, the dog died. No known necropsy was performed. No more information is expected. This case is closed.
Death
O - Unclassifiable/unassessable Reported abdominal distention, diagnosed multi organ failure, ascites and finally 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 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. In this case dog may have died due to abdominal distention, diagnosed multi organ failure and ascites. Previous exposure was well tolerated by animal. Considering limited information (e.g. health status, time to onset unknown and necropsy results are unknown), a relation to this case is unassessable.