New incident report
Incident Report Number: 2021-0351
Registrant Reference Number: USA-BAYERBAH-2020-US0062276 (Report 680514)
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 150 Research Lane, Suite 120
City: Guelph
Prov / State: ON
Country: Canada
Postal Code: N1G 4T2
Domestic Animal
Country: UNITED STATES
Prov / State: NORTH CAROLINA
Unknown
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
Animal's Owner
Dog / Chien
Pug
1
Female
13
13.608
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 an unknown date, in approximately Oct-2020, the canine exhibited pruritus and had fleas. On an unknown date, in Nov-2020, the canine died. No known necropsy was preformed.
Death
O - Unclassifiable/unassessable SLEE/fleas. Reported pruritus is not expected with appropriate topical product use. If any, skin reaction would be located at the application site of the collar. Skin disorder in this case rather associated with current flea infestation. However, presence of fleas is not a sign of inefficacy. Product is not a repellent. Fleas have to be on the animal to come into contact with the product to be killed. Fleas were reported after a flea-free time. Sudden appearance of fleas after flea-free time suggests re-infestation with fleas from environment (e.g. other untreated pets, wildlife). This may lead to new establishment of a flea population in pet真真真s environment requiring several weeks of treatment to disappear. Duration of flea infestation is unknown. Moreover, potential contributing factors such as high environmental infestation pressure not clarified. Further, fatal outcome of death is not expected following appropriate topical product application as inconsistent with product真真真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. Previous exposure was well tolerated without any adverse event. However, health details are unknown for the geriatric dog. Time to onset is long. Considering limited information (no necropsy details) provided in the case, a product relation for this case is unassessable.