New incident report
Incident Report Number: 2021-3152
Registrant Reference Number: USA-BAYERBAH-2021-US0021719 (Report 702767)
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 unknown
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Miniature Poodle
1
Male
Unknown
Unknown
Skin
Unknown / Inconnu
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Three weeks post administration, the canine exhibited unspecified neurological signs, lethargy and anorexia. It is unknown if the canine was examined or treated by a veterinarian. On an unspecified date post onset of clinical signs, in approximately 2021, the canine died. It is unknown if a necropsy was performed. No further information expected. Case closed.
Death
O - Unclassifiable/unassessable Neurological signs are not typically seen with appropriate topical product administration. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Even with oral product exposure which was not reported only transient gastrointestinal signs are expected. Other unrelated causes are probable. Reported lethargy and anorexia are unspecific and may have numerous other causes. These might be associated with other signs reported. Further reported death is 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. Limited information is provided (animal's details, health status and medical history, time to onset, necropsy details) are unknown. Overall, a product involvement is considered unassessable.