Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-3067
2. Registrant Information.
Registrant Reference Number: 2015CK075
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 Matheson Boulevard
City: Missisaugua
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.
07-MAY-15
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
25-APR-15
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. 27661
PMRA Submission No.
EPA Registration No.
Product Name: k9 advantix 20
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
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).
An 11month old 5.6kg FS miniature schnauzer was treated with 1 tube of K9 Advantix II medium dog on april 25th 2015.
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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
miniature schnauzer
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.9
7. Weight (provide a range if necessary )
5.6
kg
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
>30 min <=2 hrs / >30 min <=2 h
11. List all symptoms
System
12. How long did the symptoms last?
>3 days <=1 wk / >3 jours <=1 sem
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
Within 1 hour the dog became itchy at the application sites. The dog was treated with vanectyl P (antihistamine/steroid) and bathed with cortisooth shampoo. 4 days later the dog was recovered.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here