New incident report
Incident Report Number: 2017-6934
Registrant Reference Number: USA-BAYERBAH-2017-US0059552 (Report 445799)
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: TEXAS
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Dog (unspecified)
Other (specify)
COLLARYes
Other Units: Collar
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Australian Shepherd Dog
1
Unknown
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in 2015, an Australian Shepherd canine, of unknown signalment and condition, with concomitant medical conditions of atopic skin reaction and hairloss, had one Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner.
Death
N-Unlikely: Reported death is 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. No signs of anaphylatic reaction reported. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (approximately 2 year). Moreover, the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Time to onset is unknown. Finally, considering known safety profile of the product, product relation is unlikely. The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient.