New incident report
Incident Report Number: 2021-3796
Registrant Reference Number: USA-BAYERBAH-2021-US0027699 (Report 709400)
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 collar unknown
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
unknown
1
Unknown
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date post application, in 2021, the dog exhibited intermittent seizures and the collar was removed. It was unknown if the dog was examined by a veterinarian or if treatments were performed. The current medical status of the pet was unknown. On an unspecified date post onset of the seizures, in 2021, the dog died. It was unknown if a necropsy was performed. No more information is expected and this case is closed.
Death
O - Unclassifiable/unassessable The product is not anticipated to cause serious neurological disorder such as seizures and later reported fatal outcome of death 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. Time to onset is unknown in this case. Additionally death was reported unknown time after collar removal. Further limited information regarding animal details, current medical status, whether the dog was examined by veterinarian and necropsy details. Considering all aspects, a product relation is unassessable.