New incident report
Incident Report Number: 2021-0340
Registrant Reference Number: USA-BAYERBAH-2020-US0060915 (Report 678762)
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 150 Research Lane, Suite 120
City: Guelph
Prov / State: ON
Country: Canada
Postal Code: N1G 4T2
Domestic Animal
Country: UNITED STATES
Prov / State: WISCONSIN
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto collar Small Dog
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
German Spitz - Pomeranian
1
Male
0.153
Unknown
Skin
>6 mos <=1 yr / > 6 mois < = 1 an
>2 mos <=6 mos / > 2 mois < = 6 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date post application in approximately Mar-2020, the concomitant fleas resolved. On approximately 01-Jul-2020, the dog exhibited lethargy, fluctuations in appetite, exercise intolerance, weakness, and lateral recumbency. On an unknown date post onset clinical signs in 2020, the dog was evaluated by a veterinarian and no treatments were performed. On approximately 02-Nov-2020, the collar was removed and the now 1 year old, 15 pound, intact, male, Spitz - German Pomeranian dog, had one Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner. On approximately 16-Nov-2020, the lethargy worsened. On 26-Nov-2020, the dog exhibited dyspnea. On 29-Nov-2020, the dog was found laying in the snow and exhibited dyspnea, respiratory arrest, and the dog died. No necropsy was performed.
Death
O - Unclassifiable/unassessable Reported lethargy, fluctuations in appetite, exercise intolerance and weakness are unspecific and may have numerous other causes. Further, lateral recumbency, dyspnoea, laying in the snow, respiratory arrest and death of the dog are not expected following appropriate topical product application as inconsistent with product¿¿¿¿¿¿s pharmacological profile. Oral exposure to the collar is not expected to cause such 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. However, in this case young animal with unknown health status may have died due to respiratory disorders. Time to onset is long. No necropsy was performed. Overall, a product involvement is considered unassessable.