New incident report
Incident Report Number: 2017-4456
Registrant Reference Number: CAN-BAYERBAH-2017-CA0000054
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: CANADA
Prov / State: ONTARIO
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar Large Dog
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Unknown
1
Male
7
40.82
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
>1 wk <=1 mo / > 1 sem < = 1 mois
Yes
Unknown
Died
Other / Autre
specify Unknown
(eg. description of the frequency and severity of the symptoms
On 20-May-2017, a 7 year old, 90 pound, neutered, male, Unknown Breed canine, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On approximately 29May2017, the dog exhibited lethargy and inappetance. On 02Jun2017, the dog was examined by a veterinarian and was weak and unable to stand. Blood work and radiographs were performed and the dog was anemic and diagnosed with an auto-immune disease. The dog was administered a steroid injection and started on oral steroids and acetylsalicylic acid. On 3Jun2017, the signs were ongoing; the owner removed the collar. Follow up received on 14th June, 2017: On 07-Jun-2017, the dog was euthanized. No necropsy was performed.
Major
N - Unlikely Reported systemic signs are unspecific and may have numerous other causes. Unable to stand is not typically seen with appropriate topical product administration. Even with oral product exposure which was not reported only transient gastrointestinal signs are expected. Signs in this case likely associated with later diagnosed anemia and auto-immune disease. Anaemia and auto-immune disorder and later reported death are 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. Outcome likely consequence of the diagnosed auto-immune disorder and anemia. Time to onset is long. Other causes are more probable. Overall, sufficient information exists to rule out product involvement.