New incident report
Incident Report Number: 2021-2631
Registrant Reference Number: USA-BAYERBAH-2021-US0017236 (Report 697946)
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 large dog
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Crossbred (German Shepherd Dog x Siberian Husky)
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 unknown date in 2019, the canine had dry skin and exhibited intermittent pruritus. On an unknown date in May 2019, the canine had cancer in his hindquarters and died. No known necropsy was performed. No further information is expected. This case is closed.
Death
O - Unclassifiable/unassessable Skin disorders on other than the application site are not typically seen with topical product administration. Though initial pruritus may be seen with collar use, other skin disorders are not expected. Further reported serious signs of cancer in hindquarters followed by 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Further, animal may have died due to reported cancer in hind quarters. Overall, considering limited information is available about animal details, health status, time to onset and necropsy report, a product relation for the case is unassessable.