Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2016-6395
2. Registrant Information.
Registrant Reference Number: 2016CP374
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.
13-OCT-16
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
13-OCT-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. 27582
PMRA Submission No.
EPA Registration No.
Product Name: advantage II large dog
- Active Ingredient(s)
- IMIDACLOPRID
- PYRIPROXYFEN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
2.5
Units: mL
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).
one tube was applied to the dorsal midline of a nursing dog
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
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
cross
4. Number of animals affected
2
5. Sex
Unknown
6. Age (provide a range if necessary )
.04
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
Unknown
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
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
Unknown/Inconnu
16. How was the animal exposed?
Other / Autre
specify product was applied to a nursing dog; the two nursing puppies had the adverse event
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
a female canine cross that was nursing two 15 day old puppies, was applied one tube advantageII large dog once by the owner ; the following day the two pups had loose stool; dog was not examined by a veterinarian ; no treatment given ; unknown outcome
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
unlikely to be related