New incident report
Incident Report Number: 2020-2251
Registrant Reference Number: USA-BAYERBAH-2020-US0024428 (Report 640024)
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: PENNSYLVANIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar unknown
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Lhasa Apso
1
Male
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified dates post application, in approximately Oct 2018, the dog exhibited seizures. The dog was examined by the veterinarian; unspecified treatments were performed and the collar was removed The dog continued to have seizures on unspecified dates. On an unspecified date in Apr 2019, the dog died. It is unknown if a necropsy was performed. No further information was expected. This case is closed.
Death
O - Unclassifiable/unassessable The product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. But seizures were reported in connection with product use in dogs. However, it is known that overdose of 5 collars around the neck of adult dogs for an 8 months period and in 7-week old puppies for a 6 months period did not cause 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. Even with oral product exposure, seizures are not seen. Merely gastrointestinal signs may occur. Any action or treatment may trigger seizures in an animal with a respective disposition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Death is not expected with use of product as inconsistent with the pharmaco-toxicological product profile. However, death maybe associated with reported seizures. Time to onset is unknown. Considering low level of information (e.g. necropsy, animal details and animal health status) are unknown. Overall, a product relation is considered as unassessable.