New incident report
Incident Report Number: 2018-3595
Registrant Reference Number: USA-BAYERBAH-2018-US0043708 (Report 509329)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
Domestic Animal
Country: UNITED STATES
Prov / State: UNKNOWN
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Large Dog
Other (specify)
COLLARYes
Other Units: Collar
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Beagle
1
Male
Unknown
15.876
kg
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 mo <=2 mos / > 1 mois < = 2 mois
System
Persisted until death
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 19-Jul-2018 the canine developed application rash. The collar was removed. On 30-Jul-2018 the canine passed away. No necropsy was performed.
Death
O - Unclassifiable/unassessable The reported application site rash may occur in sensitive animals after product application. It is usually mild and transient. Sign is consistent, time to onset is long. Later 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset is long for death. Moreover, death reported after collar removal and some information missing (e.g. animal details, necropsy report). Thus, other causes should also be considered. Considering all aspects, product relation is unassessable.