New incident report
Incident Report Number: 2019-4449
Registrant Reference Number: USA-BAYERBAH-2019-US0038187 (Report 580708)
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
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto collar cat
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
Domestic Shorthair
1
Male
10
6.804
kg
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 01Jul2019, the feline weighed 8 pounds, developed pleural effusion and died. No necropsy was performed. No more information is expected. This case is closed. The intent of the call was to inquire about product use in general and not to report this event.
Death
N - Unlikely Reported pleural effusion and serious outcome of death are not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Reported weight loss is not expected either, and in this case likely associated with pleural effusion. 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. Outcome was the consequence of alternative cause of death (pleural effusion) and thus, sufficient information exists to exclude product involvement. Collar was applied previously and well tolerated by animal. Though exact time to onset is unknown, it is considerably long. Considering overall aspects, product involvement is unlikely.