New incident report
Incident Report Number: 2018-0472
Registrant Reference Number: USA-BAYERBAH-2017-US0078501 (Report 464613)
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: PENNSYLVANIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto large dog
Other (specify)
COLLARYes
Other Units: Collar
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Boxer (German Boxer)
1
Male
9
28.123
kg
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in May 2017, the canine exhibited a behavioral change, a swollen tongue, foaming at the mouth, seizure-like activity, difficulty breathing, then the canine died. No known necropsy performed. Due to the nature of the communication and in order to avoid further strain on the relationship with the reporting party, no further information will be sought. No further information is expected. Case is closed.
Death
O - Unclassifiable/unassessable Reported signs of behavioral change may occur initially after collar application. But time to onset seems too long. further reported swollen tongue, foaming at the mouth, and difficulty breathing are not expected after product application and rather associated with seizure-like episode that the dog experienced. However, 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/convulsions were reported in connection with product use in dogs and were requested by authorities to be content of the EU SPC. 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. 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. Subsequently reported death is not expected following appropriate topical product application as inconsistent with products 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Considering the product profile, product involvement is deemed unlikely, however due to limited information, case is considered unassessable.