Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2010-2900
2. Registrant Information.
Registrant Reference Number: 2010TH017
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.
16-JUN-10
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
24-MAY-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. 25131
PMRA Submission No.
EPA Registration No.
Product Name: Advantage 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 to several spots including right lumbar spine and dorsal thorax.
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
German Shepherd X
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
13
7. Weight (provide a range if necessary )
64
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
>2 mos <=6 mos / > 2 mois < = 6 mois
11. List all symptoms
System
- Skin
- Symptom - Erythema
- Symptom - Hair loss
- Symptom - Lesion
12. How long did the symptoms last?
Unknown / Inconnu
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
Unknown/Inconnu
16. How was the animal exposed?
Contact treat.area/Contact surf. traitée
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
Owner applied product mid-March. The pet presented to the veterinarian the last week of May with an area of approx 4 cm of red alopecic skin over the right lumbar spine. This spot seemed to be resolving and the hair was regrowing. A second smaller spot developed over the dorsal thorax and seemed to develop more recently and was still losing hair. The owner reports that these were the application sites of advantage when given in March. The areas are being treated with cothivet sprayed 2-3 times daily and allerderm applications 1-2 x per week. The lesions seem to be healing but are not yet fully resolved.
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 given. Exposure time is listed as greater than 1 month as advantage has at least 4 weeks activity.