New incident report
Incident Report Number: 2017-4024
Registrant Reference Number: USA-BAYERBAH-2017-US0022976
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Human
Domestic Animal
Country: UNITED STATES
Prov / State: PENNSYLVANIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar Large
Other (specify)
collarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
No
Other
Sex: Male
Age: >19 <=64 yrs / >19 <=64 ans
System
>2 mos and <=6mos />2 mois et <=6mois
No
No
Unknown
Contact with treated area
Amount of time between application and contact .033
Hour(s) / Heure(s)
What was the activity? mouthed his dog that had the collar applied
Unknown
Oral
>1 mo <= 6 mos / > 1 mois < = 6 mois
<=30 min / <=30 min
On an unspecified date in approximately Oct 2016, a (age) year old, man, in unknown condition, with a concomitant medical condition of allergies, was exposed to an unknown amount of 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar when he mouthed his dog that had the collar applied on the same day. No known direct exposure with the collar occurred and it was unknown if the collar was applied correctly to the dog. Immediately post exposure, the individual experienced an intermittent numbing sensation on the tongue. The man continued to mouth his dog and the sign continued intermittently. On an unknown date in Apr 2017, the man removed the collar from the dog and recovered without medical intervention. Follow up information received on 6th Jun 2017: No more information is expected; this case is closed.
Major
B - Possible No known direct contact reported but indirect contact can be assumed as individual mouthed the dog. Reported sign may occur after oral exposure. Though, individual has concomitant condition of allergies, considering short time to onset, a product relation is possible.
Animal's Owner
Dog / Chien
Australian Shepherd Dog
1
Male
9
20.412
kg
Skin
>24 hrs <=3 days / >24 h <=3 jours
>8 hrs <=24 hrs / > 8 h < = 24 h
System
>24 hrs <=3 days / >24 h <=3 jours
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 05-May-2017, a 9 year old, 45 pound, neutered, male, Shepherd - Australian dog, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Large Dog Collar (Flumethrin-Imidacloprid) placed around the neck by the animal owner. On approximately 06-May-2017, the dog developed a decreased appetite. On 08-May-2017, the dog died and no necropsy was performed.
Death
O - Unclassifiable/unassessable Reported anorexia is unspecific and may have numerous other causes. Time to onset is short. Further 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 anaphylaxis reported which would have occurred in close proximity to the collar application. Considering the product profile, product involvement is deemed unlikely, however due to missing information (no necropsy report), case is considered unassessable.