Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2010-6183
2. Registrant Information.
Registrant Reference Number: 2010TH039
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Road
City: Toronto
Prov / State: ON
Country: Canada
Postal Code: M9W 1G6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
14-OCT-10
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
30-SEP-10
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: K9 advantix 100
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).
Owner applied in 2 spots with the majority of product applied in 1 spot between the shoulder blades.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Golden Retriever
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.92
7. Weight (provide a range if necessary )
30.5
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 mo <= 6 mos / > 1 mois < = 6 mois
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?
>1 wk <=1 mo / > 1 sem < = 1 mois
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
No
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Fully Recovered / Complètement rétabli
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
The woner applied product Sept 29 2010 and had the pet examined Oct 4 2010. The veteriarian noted an area of dermatitis at the application site. The affected area was clipped and cleaned. The owner was to wash the area twice daily with hibitaine and spray with topagen spray. 3 weeks of clavamox was prescribed. As of Oct 21 2010 the pet was recovering well.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
Classed as moderate as treatment was provided. Exposure is listed as greater than one month as K9 advantix has at least 4 weeks activity and was not washed off. K9 advantix is to be applied in 3-4 spots, not in 1 or 2.