New incident report
Incident Report Number: 2018-2074
Registrant Reference Number: USA-BAYERBAH-2018-US0016069 (Report 481866)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississauga
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
Domestic Animal
Country: UNITED STATES
Prov / State: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Small Dog
Other (specify)
COLLARYes
Other Units: Collar
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Miniature Poodle
1
Female
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Persisted until death
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in approximately 2017, the collar was removed and an unknown flea collar was applied by the owner. On an unknown date in approximately 2017, the unknown flea collar was removed. On an unknown date post removal of both collars, in Oct2017, the canine was diagnosed with renal failure. On an unknown date in Jan2018, the canine died. No necropsy was performed.
Death
N - Unlikely Reported renal failure and later reported death 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Though time to onset is unknown for renal failure it is long for death and all signs were reported after collar removal indicating that other unrelated etiologies are more probable. In the end, considering the known product safety profile, product involvement is considered as unlikely.