Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2016-2753
2. Registrant Information.
Registrant Reference Number: 2016KP071
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
04-MAY-16
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
14-FEB-16
Product Description
7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.
Active(s)
PMRA Registration No.
PMRA Submission No.
EPA Registration No. 11556-155
Product Name: Seresto Collar - Large Dog
- Active Ingredient(s)
- Flumethrin
- IMIDACLOPRID
- Guarantee/concentration 10 %
7. b) Type of formulation.
Other (specify)
Collar
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
Other Units: collar
10. Site pesticide was applied to (select all that apply).
Site: Animal / Usage sur un animal domestique
11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).
On 29Jan2016, a 8 year old, 70 pound, neutered, female,Siberian Husky canine, in fair condition, with osteoarthritis and was overweight, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around her neck by the owner.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
Subform III: Domestic Animal Incident Report
1. Source of Report
Other
2. Type of animal affected
Dog / Chien
3. Breed
Siberian Husky
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
18
7. Weight (provide a range if necessary )
70
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
No
14. a) Was the animal hospitalized?
No
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Died
16. How was the animal exposed?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On 14Feb2016, the dog passed away from an unknown cause. A necropsy was not performed. No further information expected. Case closed. Follow up receive on 17th February 2016: The dog was also on an unknown dose of Carprofen (non Bayer) since an unknown date in 2015 for the concomitant osteoarthritis.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
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 death 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. Also dog was in fair condition, overweight and had history of osteoarthritis. Considering the known product profile and time to onset, sufficient information exists to conclude that the product did not cause the event and a product connection was deemed to be unlikely.