Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-3424
2. Registrant Information.
Registrant Reference Number: 2011TH027
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.
06-JUN-11
5. Location of incident.
Country: CANADA
Prov / State: ALBERTA
6. Date incident was first observed.
10-MAY-11
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. 27658
PMRA Submission No.
EPA Registration No.
Product Name: K9 advantix 10
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
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Maltese X Shih Tzu
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.25
7. Weight (provide a range if necessary )
1.3
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Skin
- Symptom - Hyperesthesia
- Specify - skin twitch
- Symptom - Itchy skin
- Symptom - Lesion
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
Owners applied K9 advantix May 9 2011. May 10th they noticed the dog was twitchy and was rubbing her back on things. The owners bathed her in puppy shampoo and then with Dove soap. May 11 the dog was examined in clinic and was noted to be itchy. Dexamethasone and Vanectyl P were sent home. May 12 the skin at the application site was noted to be thickened and discoloured (red/brown), the owners began to use a topical cortisone cream and the dog seemed more comfortable. May 17th the thickened skin was replaced with a few scabs and the dog was otherwise normal.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here