New incident report
Incident Report Number: 2019-5929
Registrant Reference Number: USA-BAYERBAH-2019-US0055028 (Report 597725)
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: TENNESSEE
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar Large
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Labrador Retriever
1
Male
Unknown
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>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
On approximately 28 May 2019, the dog developed generalized pruritus. On 29 May 2019, the dog died. No necropsy was performed. The intent of the call was to inquire about product use in general and not to report this event. No further information is expected. This case is closed.
Death
O - Unclassifiable/unassessable Generalized pruritus on other than the application site is not typically seen with topical product administration. Other causes (e.g. allergies) are more probable although not described. Reported death is not expected following appropriate topical product application as inconsistent with product's 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 long. Limited information was provided, the intent of the call was to inquire about product use in general and not to report this event. Overall, a product relation for the case is unassessable.