New incident report
Incident Report Number: 2020-1509
Registrant Reference Number: USA-BAYERBAH-2020-US0012738 (Report 628250)
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: UNKNOWN
Unknown
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
Male
9
4.536
kg
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in 2019 post application, the feline developed application site alopecia and the collar was removed. The feline was examined by a veterinarian and it is unknown if any treatments were performed. On an unknown date in 2019, post collar removal, the feline tested positive for an unspecified tick born disease and died; no necropsy was performed. No more information is expected. The case is closed.
Death
O - Unclassifiable/unassessable The reported application site alopecia may occur in sensitive animals after product application. It is usually mild and transient. Sign is consistent. Time to onset is unknown. Further, in this case, no ticks seen on dog. In case of attachment of ticks these will be killed and fall off the host within 24 to 48 hours after infestation without having had a blood meal, as a rule. However, attachment of single ticks and even sucking of blood and thus transfer of tick borne diseases cannot be excluded while the collar is worn and simply reflects the labeled claim of efficacy that is not 100% against ticks especially when infestation pressure is high. Thus, infection with tick borne diseases despite wearing a collar can occur exceptionally and is consistent with the product's claimed efficacy. This issue is addressed in the product information. 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. In this case, death may be outcome of diagnosed tick borne disease. However, in this except application site sign other signs were reported after collar removal. Considering unknown time to onset, a product relation is unassessable.