New incident report
Incident Report Number: 2018-0445
Registrant Reference Number: USA-BAYERBAH-2017-US0076461 (Report 462407)
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
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
German Shepherd Dog
1
Male
3
73.091
kg
Skin
>24 hrs <=3 days / >24 h <=3 jours
>24 hrs <=3 days / >24 h <=3 jours
System
>1 wk <=1 mo / > 1 sem < = 1 mois
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 15Nov2017, the dog developed a rash on his ears, chest, abdomen and groin and he developed a seizure NOS and Seresto was immediately removed and the dog was bathed with an unspecified shampoo. On an undetermined date post product removal, the Seresto collar was placed on the table and it sat for two days and the finish was eaten away where the Seresto collar had been sitting. The dog had not been evaluated by a veterinarian. On 29Nov2017, the dog developed a seizure NOS, was lethargic and drooling. Approximately 10 minutes post clinical sign onset, the dog appeared to be improving and was taken outside for some fresh air. Approximately 20 minutes post clinical sign onset, the dog was acting happy and was running outside and he collapsed and died in front of the animal owner. The dog had not been evaluated by a veterinarian. No necropsy was performed.
Death
O- Unassessable: Reported rash on other than the application site is not typically seen with topical product administration. Though initial pruritus may be seen with collar use, other skin disorder is not expected. The product is not anticipated to cause serious neurological disorder such as seizure after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. But seizure was 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 (unknown if occurred), seizure is not seen. Merely gastrointestinal signs may occur. Any action or treatment may trigger seizures in an animal with a respective disposition. As pet showed seizure prior to product use, seizure was likely related to this underlying condition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Drooling and lethargy are unspecific and may be associated with the later reported seizures. Reported serious signs such as collapse and death are not expected following appropriate topical product application as inconsistent with products pharmacological profile. Moreover, later reported signs observed after collar removal, hence not product related. Though time to onset is consistent for reported rash, it is long for other reported signs. Considering all aspects, a product involvement is unassessable. Clinical signs of sudden death, as observed in this case, usually indicate a heart abnormality. The collar was removed 13 days prior, so no active ingredient would be expected to be present. No necropsy was performed, so cause of death can not be determined.