Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2012-5174
2. Registrant Information.
Registrant Reference Number: 2012TH127
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.
Domestic Animal
4. Date registrant was first informed of the incident.
21-AUG-12
5. Location of incident.
Country: CANADA
Prov / State: NEWFOUNDLAND
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. 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).
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
Britany Spaniel
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
2
7. Weight (provide a range if necessary )
67
lbs
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
>3 days <=1 wk / >3 jours <=1 sem
11. List all symptoms
System
- Skin
- Symptom - Erythema
- Symptom - Pain
- Blood
- Symptom - Bleeding
- Specify - dried blood
- Skin
- Symptom - Discolouration
- Specify - discolouration of hair at application site
- Symptom - Red skin
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Unknown
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?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
Owner applied product and 3 days after the second dose noticed dried blood at the application site. There was some discolouration of the hair, red skin and pain at the application site. An exam was arranged with her clinic but the results have not yet been provided.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here