Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-5914
2. Registrant Information.
Registrant Reference Number: 2014CP175
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Rd
City: Toronto
Prov / State: ON
Country: Canada
Postal Code: M9W 1G6
3. Select the appropriate subform(s) for the incident.
Human
4. Date registrant was first informed of the incident.
05-DEC-14
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
19-NOV-14
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. 27659
PMRA Submission No.
EPA Registration No.
Product Name: K9advantix100
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
4
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 a dog monthly from June 01 to Nov 01 2014
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
Subform II: Human Incident Report (A separate form for each person affected)
1. Source of Report.
Data Subject
2. Demographic information of data subject
Sex: Female
Age: Unknown / Inconnu
3. List all symptoms, using the selections below.
System
4. How long did the symptoms last?
Unknown / Inconnu
5. Was medical treatment provided? Provide details in question 13.
Yes
6. a) Was the person hospitalized?
No
6. b) For how long?
7. Exposure scenario
Non-occupational
8. How did exposure occur? (Select all that apply)
Contact with treated area
What was the activity? petting her dog
9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)
None
10. Route(s) of exposure.
Skin
11. What was the length of exposure?
Unknown / Inconnu
12. Time between exposure and onset of symptoms.
Unknown / Inconnu
13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)
dog owner has had dermatitis on her hands off and on during summer 2014; her dermatologist suggested the dermatitis was caused by patting a dog that was treated with K9advantix monthly from June 01 to Nov 01 2014. was given oral atarax and tiamol cream as treatment
To be determined by Registrant
14. Severity classification.
Moderate
15. Provide supplemental information here.