New incident report
Incident Report Number: 2021-3190
Registrant Reference Number: USA-BAYERBAH-2021-US0018656 (Report 699708)
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: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto collar Small dog
Other (specify)
COLLARYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Chihuahua
1
Female
8
2.4948
kg
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date post application, in Sep2020, the dog was examined by a veterinarian for annual exam and exhibited a musculoskeletal disorder; no treatment was provided. On 03Oct2020, the owner removed the collar, the dog was bathed with an unspecified shampoo and a new Seresto Small Dog (Flumethrin-Imidacloprid) collar was placed around the neck by the owner. Approximately 1 hour post collar placement the dog was taken on a walk and exhibited panting and lethargy. The owner had to carry the dog home. On 04Oct2021, the dog exhibited a seizure, groaning, blood from an unknown, she stopped breathing and died. No necropsy was preformed.
Death
O - Unclassifiable/unassessable Initially reported musculoskeletal disorder is not expected after appropriate product use. Time to onset is unknown. Other causes should be considered. Reported lethargy and groaning are unspecific signs and may have numerous other causes. Sign may occur initially after collar administration. Further, panting, bleeding, serious signs of seizure, respiratory arrest and fatal outcome of 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. Time to onset is short after reapplication of collar. Further necropsy details are unknown. Other unrelated causes should be considered. Moreover, previous collar application was well tolerated. Considering all aspects, a product relation is unassessable.