Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2016-0718
2. Registrant Information.
Registrant Reference Number: 2015KP353
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.
15-JAN-16
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
Unknown
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
- Active Ingredient(s)
- Flumethrin
- IMIDACLOPRID
- Guarantee/concentration 10 %
7. b) Type of formulation.
Liquid
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 an unspecified date in Nov-2014, a 10 year old, Unknown weight, neutered, male, Border Collie crossbred canine, in fair condition with no known concomitant medical conditions,had 1 Seresto Dog (unspecified) (Flumethrin-Imidacloprid)collar placed around the neck by the owner.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Other
2. Type of animal affected
Dog / Chien
3. Breed
Border Collie Crossbreed
4. Number of animals affected
1
5. Sex
Male
Female
6. Age (provide a range if necessary )
10
7. Weight (provide a range if necessary )
Unknown
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
>6 mos / > 6 mois
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Neoplasia
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 an unspecified date in May 2015 the dog died from cancer. It is unknown if a necropsy was performed. No further information is expected. Case is closed.
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. Death was the consequence of reported cancer and sufficient information exists to rule out product involvement. Cancer is neither expected nor inline with products pharmacotoxicological profile. An overdose of 5 collars around the neck was investigated in adult dogs for an 8 months
period without causing serious signs. Time to onset is exceptionally long. Even though it is unknown if necropsy was performed, considering all aspects product relation is unlikely.