New incident report
Incident Report Number: 2020-5418
Registrant Reference Number: USA-BAYERBAH-2020-US0041386 (Report 658345)
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: RHODE ISLAND
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto cat
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
Unknown
1
Unknown
Unknown
Unknown
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 16-Jul-2020, fleas were visualized on the cat and the collar was removed. On approximately 23-Jul-2020, the cat had an unspecified dose of Fipronil applied by the animal owner. On approximately 06-Aug-2020, the cat developed anorexia and died. No necropsy was performed. The reporting party did not call to report the death of this animal but to inquire about product use on another animal. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. No further information is expected. This case is closed.
Death
O - Unclassifiable/unassessable SLEE/fleas. 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. Unknown how many fleas are found on the cat. Moreover, potential contributing factors such as high environmental infestation pressure not clarified. Later reported anorexia is an unspecific sign and may have numerous other causes. Sign may occur initially after collar administration but is not expected to appear after long time. Other causes are more probable. 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 sign 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 sign. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. In this case, anorexia and death were reported long time after collar removal hence not product related. Moreover, the reporting party did not call to report the death of this animal but to inquire about product use on another animal. Time to onset is too long. Other causes are more probable. Considering overall aspects, a product relation for this case is unassessable.