New incident report
Incident Report Number: 2018-3588
Registrant Reference Number: USA-BAYERBAH-2018-US0042284 (Report 508468)
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: TEXAS
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
Unknown
Animal's Owner
Cat / Chat
Unknown
1
Male
Unknown
Unknown
Skin
>6 mos <=1 yr / > 6 mois < = 1 an
>2 mos <=6 mos / > 2 mois < = 6 mois
System
Persisted until death
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 15-Apr-2017, the cat exhibited the behavior of not wanting to hunt and lethargy. On approximately 15-May-2017, the cat died. No necropsy was performed. Due to the sensitive nature of the communication, certain relevant details were not obtained, nor will such be sought. The reason for the initial communication was to discuss use of the product and not to report the death in this event. No further information is expected. This case is closed. Note: Previous exposure was well tolerated by animal.
Death
N - Unlikely Reported behavior of not wanting to hunt and lethargy are unspecific and may have numerous other causes. 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. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (almost a year). Moreover, the owner did not believe in product involvement either as the reason for the initial communication was to discuss use of the product and not to report the death in this event. Further, previous exposure was well tolerated by animal. Time to onset is long. Even though no necropsy was performed, considering all aspects, a product involvement is considered unlikely.